2020-09-09 — *See MRI Scan Parameters in MRI Ready Systems Manual. Gallant™ Single-Chamber ICD ... Refer to the User's Manual for detailed intended use, indications,.
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 myMerlinPulse™ mobile application.
Stored Electrograms 30 minutes (1 user programmable discrimination channel), up to one minute programmable pre-trigger data per VT/VF electrograms; additional triggers include lead noise detection, non-sustained ventricular oversensing, morphology template updates, magnet reversion, noise reversion Therapy Summary Diagram of therapies delivered
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE GallantTM Single-Chamber ICD CDVRA500Q Compatible with myMerlinPulseTM App Product Highlights · Bluetooth® Low Energy (LE) communication enabling smartphone connectivity through data encryption · 40J delivered energy safety shock option for enhanced safety margin · 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 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 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 is designed to 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 · 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 an MR Conditional lead for full-body scans using a 1.5T or 3T (Tesla) field strength MRI scanner* · New battery provides higher capacity than previous QHR batteries to offer superior longevity/volume ratio · DF4 connector designed to streamline defibrillation connections into a single terminal pin and reduce the number of set screws · Cold can programmability provides an additional RVSVC Shock Configuration to decouple the can from the shocking vector parameters · The CorVueTM thoracic impedance feature measures transthoracic impedance changes over time to provide additional insight into the patient's heart failure condition · Dual patient notification: audio notification through the device and visual notification via myMerlinPulseTM app Ordering Information Contents: Cardiac Pulse Generator MODEL NUMBER DIMENSIONS (H x W x T.MM) CDVRA500Q 63 x 51 x 12 *See MRI Scan Parameters in MRI Ready Systems Manual. WEIGHT (G) 69 VOLUME (CC) 30 CONNECTOR DE FIB RILL ATION DF4 CONNECTOR SENSE/PACE DF4 GallantTM Single-Chamber ICD CDVRA500Q Product Specifications PHYSICAL SPECIFICATIONS Models Telemetry Delivered/Stored Energy Volume Weight Size Defibrillation Lead Connections Sense/Pace Lead Connections High-Voltage Can CDVRA500Q Bluetooth® LE Communication 40/45 J 30 cc 69 g 63 x 51 x 12 mm DF4 DF4 Electrically active titanium can PARAMETER SETTINGS Sensing/Detection SenseAbilityTM Sensing Algorithm Low Frequency Attenuation Threshold Start Decay Delay Ventricular Sense Refractory Detection Zones SVT Discriminators Discrimination Modes SVT Upper Limit SVT Discrimination Timeout Monitor Mode Reconfirmation SecureSenseTM RV Lead Noise Discrimination Algorithm VF Therapy Assurance Automatic Sensitivity Control adjustment for ventricular events On; Off Post-Sensed: 50; 62.5; 75; 100% Post-Paced: Auto; 0.2-3.0 mV Post-Sensed: 0-220 ms Post-Paced: Auto; 0-220 ms 125; 157 ms 3 zone programming - 1 zone, 2 zones or 3 zones (VT-1, VT-2, VF) Sudden Onset, Interval Stability; Sinus Interval History; Morphology Discrimination (Far Field MDTM or Original MD) with Automatic Template Update On; Passive; Off 150-240 bpm 20s-60 min; Off Detection, discrimination and diagnostics, no therapy delivery (VT or VT-1 zone) Continuous sensing during charging On; On with Timeout; Passive; Off On; Off 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 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 in increments of 5 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 High-Voltage Therapy DynamicTxTM Over-current Detection Algorithm DeFT ResponseTM Technology High-Voltage Output Mode Waveform RV Polarity Electrode Configuration On; Off Programmable pulse width for P1/P2 and tilt Fixed Pulse Width; Fixed Tilt Biphasic; Monophasic Cathode (-); Anode (+) RV to Can; RV to SVC/Can; RV to SVC Bradycardia Pacing Permanent Modes Temporary Modes Activity Sensor Programmable Rate Parameters Pulse Amplitude Pulse Width Ventricular AutoCaptureTM Pacing System Rate Responsive V Pace Refractory Off; VVI(R) Off; VVI; VOO On; Passive; Off Base Rate (bpm); Rest Rate (bpm); Maximum Sensor Rate (bpm); Hysteresis Rate (bpm); Rate Hysteresis with Search 0.25-7.5 V 0.05, 0.1-1.5 ms On; Off On; Off IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE Post-Therapy Pacing (Independently programmable from Bradycardia and ATP) Post-Shock Pacing Mode Post-Shock Base Rate Post-Shock Pacing Duration Off; VVI 30-100 in increments of 5 bpm Off; 0.5; 1; 2.5; 5; 7.5; or 10 min Device Testing/Induction Methods DC FibberTM Induction Method Pulse Duration Burst Fibber Cycle Length Noninvasive Programmed Stimulation (NIPS) 0.5-5.0 sec 20-100 ms 2-25 stimuli with up to three extra stimuli 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 BatteryAssuranceTM alert, Possible HV circuit damage, HV charge timeout, Long charge time for Capacitor Maintenance, Device at ERI, Ventricular pacing lead impedance out of range, High-voltage lead impedance out of range, 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 1-16 10; 22 hours Electrograms and Diagnostics Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics Trends Histograms Real-Time Measurements (RTM) CorVue Thoracic Impedance CorVue Thoracic Impedance Threshold 30 minutes (1 user programmable + discrimination channel), up to one minute programmable pre-trigger data per VT/VF electrograms; additional triggers include lead noise detection, non-sustained ventricular oversensing, morphology template updates, 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 HV lead impedance, Ventricular pacing lead impedance, Ventricular signal amplitude, Ventricular capture threshold, Exercise and activity trending, DirectTrendTM reports up to 1 year Event Histogram; Ventricular Heart Rate Histogram; Pacing lead impedances; High-voltage lead impedances; and Signal amplitudes On; Off 8-18 days MRI Settings Tachy Therapy MRI Mode MRI Base Rate MRI Pulse Amplitude MRI Pulse Width MRI Pulse Configuration MRI Timeout Disabled VOO; Pacing Off 30-100 bpm 5.0 or 7.5 V 1.0 ms Bipolar Off; 3; 6; 9; 12; 24 hours MRI Scan Parameters LEAD MODEL MAGNET (TESLA) DurataTM Defibrillation Lead 7120Q (lead lengths: 58, 65 cm) 7122Q (lead lengths: 58, 65 cm) 1.5T / 3T OptisureTM Lead LDA220Q (lead lengths: 58, 65 cm) LDA210Q (lead lengths: 58, 65 cm) 1.5T / 3T 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 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 One St. Jude Medical Drive St. Paul, MN 55117 USA Tel: 651 756 2000 TM Indicates a trademark of the Abbott group of companies. Indicates a third-party trademark, which is property of its respective owner. Bluetooth and the Bluetooth logo are registered trademarks of Bluetooth SIG, Inc. © 2020 Abbott. All Rights Reserved. MAT-2005511 v2.0 | Item approved for U.S. use only.Adobe PDF Library 15.0 Adobe InDesign 15.1 (Macintosh)