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Datasheet for Abbott models including: CDDRA300T Entrant Dual Chamber ICD, CDDRA300T, Entrant Dual Chamber ICD, Dual Chamber ICD, Chamber ICD
Entrant ICD and CRT-D Ordering Information | Abbott
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DocumentDocumentIMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE EntrantTM Dual Chamber ICD CDDRA300T Product Highlights · Bluetooth® Low Energy (LE) communication enabling smartphone connectivity through data encryption · DeFT ResponseTM technology offers noninvasive programming options to optimize rescue therapy to each patient's unique physiology and changing conditions · VF Therapy Assurance decreases time to treatment for arrhythmias in patients who are likely to be hemodynamically unstable · Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high-voltage shock · ShockGuardTM technology with DecisionTxTM programming designed to reduce inappropriate therapy and minimize the need for programming adjustments at implant SecureSenseTM RV lead noise discrimination algorithm detects sustained lead noise and records short bursts of oversensing that would otherwise go unnoticed or potentially lead to one or more inappropriate shocks Far Field MDTM morphology discrimination and chamber onset discrimination enhance SVT and VT discrimination for reduced inappropriate therapies · SenseAbilityTM sensing algorithm feature provides the flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity Compatible with myMerlinPulseTM app · DynamicTxTM over-current detection algorithm automatically changes shock configurations to ensure delivery of high-voltage therapy when high current is detected · MRI Ready device tested in combination with MR Conditional leads for full-body scans using a 1.5T or 3T (Tesla) field strength MRI Scanner* · Cold can programmability provides an additional RVSVC shock configuration to decouple the can from the shocking vector parameters · Premature Atrial Contraction (PAC) Response to avoid pacing the atrium in a vulnerable zone · Physiologic rate responsive AV Delay and PVARP · Dual patient notification: audio notification through the device and visual notification via myMerlinPulseTM app · The CorVueTM thoracic impedance feature measures transthoracic impedance changes over time to provide additional insight into the patient's heart failure condition Ordering Information Contents: Cardiac Pulse Generator MODEL NUMBER CDDRA300T DIMENSIONS (L × W × H) (MM) WEIGHT (G) VOLUME (CC) 73 × 51 × 12 72 35 CONNECTOR CONNECTOR DEFIBRILLATION SENSE/PACE DF-1 IS-1 *See MRI Scan Parameters in MRI-Ready Systems Manual. EntrantTM Dual Chamber ICD CDDRA300T ICD DEVICE Product Specifications PARAMETER SPECIFICATIONS Model Telemetry Delivered/Stored Energy Volume Weight Size Defibrillation Lead Connection Atrial Sense/Pace Lead Connection Ventricular Sense/Pace Lead Connection High-Voltage Can Parameter Sensing/Detection SenseAbilityTM Sensing Algorithm CDDRA300T Bluetooth® LE Communication 36/39 J 35 cc 72 g 73 × 51 × 12 mm DF-1 IS-1 in-line bipolar IS-1 in-line bipolar Electrically active titanium can Settings Automatic Sensitivity Control adjustment for atrial and ventricular events Low Frequency Attenuation Threshold Start Decay Delay Ventricular Sense Refractory Detection Zones SVT Discriminators Monitor Mode Discrimination Modes SVT Upper Limit SVT Discrimination Timeout Reconfirmation SecureSenseTM RV Lead Noise Discrimination Algorithm VF Therapy Assurance Antitachycardia Pacing Therapy ATP Configurations ATP in VF Zone ATP Upper Rate Cutoff Burst Cycle Length Min. Burst Cycle Length Readaptive Number of Bursts Number of Stimuli Add Stimuli per Burst ATP Pulse Amplitude ATP Pulse Width High-Voltage Therapy DynamicTxTM Over-current Detection Algorithm DeFT ResponseTM Technology On; Off Post-Sensed: 50; 62.5; 75; 100% Post-Paced, Atrial: 0.2-3.0 mV Post-Paced, Ventricular: Auto, 0.2-3.0 mV Post-Sensed: 0-220 ms Post-Paced, Atrial: 0-220 ms Post-Paced, Ventricular: Auto, 0-220 ms 125; 157 ms 3 zone programming -- 1 zone; 2 zones; or 3 zones (VT-1; VT-2; VF) AV Rate Branch; Arrhythmia Onset (Chamber Onset or Sudden Onset); Interval Stability; AV Association; Morphology Discrimination (Far Field MDTM Morphology Discrimination or Original MD) with Automatic Template Update Detection; Discrimination; Diagnostics; No therapy delivery (VT or VT-1 zone) On; Passive; Off 150-240 bpm 20s-60 min; Off Continuous sensing during charging On; On with Timeout; Passive; Off On; Off Ramp; Burst; Scan; 1 or 2 schemes per VT zone ATP While Charging; ATP Prior to Charging; Off 150-300 bpm Adaptive (50%-100%); Fixed (200-550 ms) 150-400 ms On; Off 1-15 2-20 On; Off 7.5 V independent from Bradycardia and Post-Therapy Pacing 1.0 or 1.5 ms independently programmable from bradycardia and post-therapy pacing On; Off Programmable pulse width for P1/P2 and tilt EntrantTM Dual Chamber ICD CDDRA300T ICD DEVICE Product Specifications High-Voltage Therapy High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Waveform Biphasic; Monophasic RV Polarity Cathode (-); Anode (+) Electrode Configuration RV to Can; RV to SVC/Can; RV to SVC Bradycardia Pacing Permanent Modes DDD(R); DDI(R); VVI(R); AAI(R); Off Temporary Modes DDD; DDI; VVI; AAI; AAT; DOO; VOO; AOO; Off Activity Sensor On; Passive; Off Programmable Rate and Delay Parameters Base Rate (bpm); Rest Rate (bpm); Maximum Tracking Rate (bpm); Maximum Sensor Rate (bpm); Paced AV Delay (ms); Sensed AV Delay (ms); Rate Responsive AV Delay; Hysteresis Rate (bpm); Rate Hysteresis with Search Pulse Amplitude 0.25-7.5 V Pulse Width 0.05 ms; 0.1-1.5 ms Ventricular AutoCaptureTM Pacing System On; Off ACapTM Confirm Feature On; Monitor; Off QuickOptTM Timing Cycle Optimization Sensed/Paced AV delay Auto Mode Switch (AMS) DDI(R); VVI(R); Off Atrial Tachycardia Detection Rate 110-300 bpm AMS Base Rate 40; 45; ... 135 bpm Rate Responsive PVARP Low; Medium; High; Off Rate Responsive V Pace Refractory On; Off PAC Response On; Off PAC Response Interval 200-400 ms PMT Detection/Termination Atrial Pace; Passive; Off Ventricular Intrinsic Preference (VIPTM) On (50-200 ms); Off Post-Therapy Pacing (Independently programmable from Bradycardia and ATP) Post-Shock Pacing Mode AAI; VVI; DDI; DDD; Off Post-Shock Base Rate 30-100 bpm Post-Shock Pacing Duration 0.5; 1; 2.5; 5; 7.5; or 10 min; Off Device Testing/Induction Methods DC FibberTM Induction Method Pulse Duration 0.5-5.0 sec Burst Fibber Cycle Length 20-100 ms Noninvasive Programmed Stimulation (NIPS) 2-25 stimuli with up to 3 extra stimuli EntrantTM Dual Chamber ICD CDDRA300T ICD DEVICE Product Specifications Patient Notifiers Programmable Notifiers (On; Off) Device Parameter Reset Entry into Backup VVI Mode Auditory Duration Number of Audio alerts per Notification Number of Notifications Time Between Notifications Electrograms and Diagnostics Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics AT/AF Burden Trend Ventricular HV Lead Impedance Histograms and Trends PMT Data Real-Time Measurements (RTM) CorVueTM Thoracic Impedance CorVue Thoracic Impedance Threshold MRI Settings Tachy Therapy MRI Mode MRI Base Rate MRI Paced AV Delay MRI Pulse Amplitude MRI Pulse Width MRI Pulse Configuration MRI Timeout BatteryAssuranceTM alert; Possible HV circuit damage; HV charge timeout; Long charge time for Capacitor Maintenance; Device at ERI; Atrial pacing lead impedance out of range. Ventricular pacing lead impedance out of range; High-voltage lead impedance out of range; AT/AF Episode duration; AT/AF Burden; High ventricular rate during AT/AF; SecureSenseTM lead noise detection; Non-sustained ventricular oversensing; Ventricular pacing percentage greater than limit On On 2; 4; 6; 8; 10; 12; 14; 16 sec 2 116 10; 22 hours Up to 15 minutes (2 user programmable + discrimination channel); up to one minute programmable pretrigger data per VT/VF electrograms; additional triggers include lead noise detection; non-sustained ventricular oversensing; morphology template updates; atrial episode; PMT termination; PAC response; magnet reversion; noise reversion Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device-initiated charging Trend data and counts Multi-Vector Trend Data Event Histogram; AV Interval Histogram; Mode Switch or AT/AF Duration Histogram; Peak Filtered Atrial Rate during Atrial Arrhythmia Histogram; Atrial Heart Rate Histogram; Ventricular Heart Rate Histogram; AT/AF Burden; Exercise and Activity Trending; V Rates during AMS; DirectTrendTM reports up to 1 year Information regarding PMT detections Pacing lead impedances; High-voltage lead impedances; Signal amplitudes On; Off 818 days Disabled DOO; VOO; AOO; Pacing Off 30-100 bpm 25-120 ms 5.0 or 7.5 V 1.0 ms Bipolar 3; 6; 9; 12; 24 hours; Off EntrantTM Dual Chamber ICD CDDRA300T ICD DEVICE MRI SCAN PARAMETERS Lead Model DurataTM Defibrillation Lead 7120 (lead lengths: 60, 65 cm) 7122 (lead lengths: 60, 65 cm) OptisureTM Lead LDA220 (lead lengths: 60, 65 cm) LDA210 (lead lengths: 60, 65 cm) TendrilTM STS Pacing Lead 2088TC (lead lengths: 46, 52 cm) TendrilTM MRI Lead LPA1200M (lead lengths: 46, 52 cm) UltiPaceTM Pacemaker Lead LPA1231 (Lead lengths 46, 52 cm) Magnet (Tesla) 1.5 T / 3 T 1.5 T / 3 T 1.5 T / 3 T 1.5 T 1.5 T / 3 T RF Transmit Conditions Scan Region Normal Operating Mode Full-body For additional information about specific MR Conditional ICDs and leads, including scan parameters, warnings, precautions, adverse conditions to MRI scanning, and potential adverse events, please refer to the Abbott MRI-Ready Systems Manual at medical.abbott/manuals. Rx Only Brief Summary: This product is intended for use by or under the direction of a Physician. Prior to using these devices, please review the Instructions for Use for acomplete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Intended Use: The Implantable Cardioverter Defibrillator (ICD) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. The myMerlinPulseTM mobile application is intended for use by people who have an Abbott Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient's implanted heart device to the patient's healthcare provider. Indications: The ICD devices are indicated for automated treatment of life-threatening ventricular arrhythmias. In addition, dual chamber ICD devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias. MR Conditional ICDs are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction. The myMerlinPulseTM mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices. Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction. The myMerlinPulseTM mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices. Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following: , Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins. Refer to the User's Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events. No potential adverse events have been identified with use of the myMerlinPulseTM mobile application. Abbott 15900 Valley View Court, Sylmar, CA 91342 Tel: +1 818 362 6822 Abbott.com TM Indicates a trademark of the Abbott group of companies. Indicates a third party trademark, which is property of its respective owner. © 2024 Abbott. All Rights Reserved. MAT-2400589 v2.0 | Item approved for U.S. only.