Medtronic Azure™ S SR MRI SureScan™ Pacemaker
Model W3SR01
Physical Characteristics
| Volumea | 12.25 cm³ |
| Mass | 22.5 g |
| H x W x Db | 42.6 mm x 50.8 mm x 7.4 mm |
| Radiopaque IDc | RNA |
| Surface area of titanium device can | 33.48 cm² |
| Materials in contact with human tissued | Titanium, polyurethane, silicone rubber |
| Battery | Lithium-hybrid CFx silver vanadium oxide |
a Volume with connector holes unplugged.
b Grommets may protrude slightly beyond the can surface.
c The radiopaque ID, which includes a Medtronic-identifier symbol, can be viewed in a fluoroscopic image of the device.
d These materials have been successfully tested for the ability to avoid biological incompatibility. The device does not produce an injurious temperature in the surrounding tissue during normal operation.
Replacement Indicators
| Recommended Replacement Time (RRT) | ≤ 2.63 V on 3 consecutive daily automatic measurements |
| Elective Replacement Indicator (ERI) | 3 months after RRT |
| End of Service (EOS) | 3 months after ERI |
Pacing Parameters
Modes, Rates, and Intervals
| Parameter | Programmable values |
|---|---|
| Mode | VVIR; VVI; VOO; OVO |
| Lower Ratea | 30; 35 ... 60; 70; 75 ... 150 bpm |
a The corresponding Lower Rate Interval can be calculated as follows: Lower Rate Interval (ms) = 60,000/Lower Rate.
Key Features
- BlueSync™ ready
- Over 13 years longevitya
- Approved for 1.5T and 3T MRI usea
a Medtronic Azure S SR MRI SureScan W3SR01 Device Manual. M964357A001 B. Accessed September 13, 2017.
RV Parameters
| Parameter | Programmable values |
|---|---|
| RV Amplitude | 0.5; 0.75 ... 3.5 ... 5; 5.5; 6; 8 V |
| RV Pulse Width | 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 ... 1.5 ms |
| RV Sensitivityb | 0.45; 0.60; 0.90; 1.20; 2.00; 2.80; 4.00; 5.60; 8.00; 11.30 mV Unipolar: 2.80 mV Bipolar: 0.90 mV |
| RV Pace Polarity | Bipolar; Unipolar |
| RV Sense Polarity | Bipolar; Unipolar |
| RV Lead Monitor | Monitor Only; Adaptive |
| Min Limit | 200 Ω; 300 Ω; 400 Ω; 500 Ω |
| Max Limit | 1,000 Ω; 1,500 Ω; 2,000 Ω; 3,000 Ω |
a When RV Amplitude is 8 V, RV Pulse Width must be less than 1.3 ms.
b This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing operations.
RV Capture Management™ Parameters
| Parameter | Programmable values |
|---|---|
| RV Capture Management™ | Adaptive; Monitor; Off |
| RV Amplitude Safety Margin | 1.5x; 2.0x; 2.5x; 3.0x |
| RV Minimum Adapted Amplitude | 1.0; 1.5; 2.0; 2.5; 3.0; 3.5 V |
| RV Acute Phase Remaining | Off; 30; 60; 90; 120; 150 days |
Blanking Periods
| Parameter | Programmable values |
|---|---|
| V. Blank Post VP | 150; 160 ... 200 ... 320 ms |
| V. Blank Post VS | 120; 130 ... 170; 200; 220; 250; 280; 300; 320 ms |
Rate Response Pacing Parameters
| Parameter | Programmable values |
|---|---|
| Upper Sensor Rate | 80; 85 ... 130 ... 175 bpm |
| ADL Rate | 60; 65 ... 95 ... 170 bpm |
| Rate Profile Optimization | On; Off |
| ADL Response | 1; 2; 3; 4; 5 |
| Exertion Response | 1; 2; 3; 4; 5 |
| Activity Threshold | Low; Medium Low; Medium High; High |
| Activity Acceleration | 15; 30; 60 s |
| Activity Deceleration | Exercise; 2.5; 5; 10 min |
| ADL Set Point | 5; 6 ... 40; 42 ... 80 |
| UR Set Point | 15; 16 ... 40; 42 ... 80; 85 ... 180 |
Sleep Parameters
| Parameter | Programmable values |
|---|---|
| Sleep | On; Off |
| Sleep Rate | 30; 35 ... 50; 55; 60; 70; 75 ... 100 bpm |
| Bed Time | 00:00; 00:10 ... 22:00 ... 23:50 |
| Wake Time | 00:00; 00:10 ... 07:00 ... 23:50 |
MRI SureScan™ Parameters
| Parameter | Programmable values |
|---|---|
| MRI SureScan™ | On; Off |
| MRI Pacing Mode | VOO; OVO |
| MRI Pacing Rate | 60; 70; 75; 80 ... 120 bpm |
Additional Pacing Features
| Parameter | Programmable values |
|---|---|
| Rate Hysteresis | Off; 30; 40 ... 80 bpm |
Tachyarrhythmia Parameters
Tachyarrhythmia Detection Parameters
| Parameter | Programmable values |
|---|---|
| VT Monitor | Monitor; Off |
| VT Monitor Interval (Rate)a | 280; 290 ... 360 ... 500 ms |
| RV Sensitivityb,c | 0.45; 0.60; 0.90; 1.20; 2.00; 2.80; 4.00; 5.60; 8.00; 11.30 mV Bipolar: 0.9 mV Unipolar: 2.80 mV |
a The measured intervals are truncated to a 10 ms multiple (for example, 457 ms becomes 450 ms). The device uses this truncated interval value when applying the programmed criteria and calculating interval averages.
b This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing operations.
c The device complies with the requirements of ISO 14708-2 when the sensitivity threshold is programmed to 2.0 mV or higher.
Data Collection Parameters
| Parameter | Programmable values |
|---|---|
| EGM 1 Source | Can to RVring; RVtip to RVring; RVtip to Can |
| EGM 1 Range | ±1; ±2; ±4; ±8; ±12; ±16; ±32 mV |
| EGM 2 Source | Can to RVring; RVtip to RVring; RVtip to Can |
| EGM 2 Range | ±1; ±2; ±4; ±8; ±12; ±16; ±32 mV |
| EGM 3 Source | RVtip to RVring; Can to RVring; RVtip to Can |
| EGM 3 Range | ±1; ±2; ±4; ±8; ±12; ±16; ±32 mV |
| Monitored | EGM1 and EGM2; EGM1 and EGM3; EGM2 and EGM3 |
| Pre-arrhythmia EGM | Off; On - 1 month; On - 3 months; On Continuous |
| Device Date/Timea | (select Time Zone) |
| Holter Telemetry | Off; 0.5; 1; 2; 4; 8; 16; 24; 36; 46 hr |
| Wireless Telemetry with Monitor | On; Off |
a The times and dates stored in episode records and other data are determined by the Device Date/Time clock.
System Test Parameters
Pacing Threshold Test Parameters
| Parameter | Selectable values |
|---|---|
| Test Type | Amplitude; Pulse Width |
| Chamber | RV |
| Decrement after | 2; 3 ... 15 pulses |
| RV Pace Polarity | Unipolar; Bipolar |
| Modea | VVI; VOO |
| Lower Rate | 30; 35 ... 60; 70; 75 ... 150 bpm |
| RV Amplitude | 0.25; 0.5 ... 5; 5.5; 6; 8 V |
| RV Pulse Width | 0.03; 0.06; 0.1; 0.2 ... 1.5 ms |
| V. Pace Blanking | 150; 160 ... 320 ms |
Sensing Test Parameters
| Parameter | Selectable values |
|---|---|
| Modea | VVI; OVO |
| Lower Rate | 30; 35 ... 60; 70; 75 ... 120 bpm |
a The selectable values for this parameter depend on the programmed pacing mode.
Medtronic CareAlert™ Parameters
Clinical Management Alerts
| Parameter | Programmable values |
|---|---|
| Monitored VT Episode Detected | Off; On |
a There is no observation for Cumulative Right Ventricular Pacing > 40%.
b Alert triggered if cumulative percent of right ventricular pacing exceeds 40% for 7 consecutive days.
Lead/Device Integrity Alerts
| Parameter | Programmable values | |
|---|---|---|
| Low Battery Voltage RRT | On; Off | |
| Lead Impedance Out of Range | On; Off | |
| Lead Impedance | RV Pacing Enable | On; Off |
| RV Pacing Less than | 200 Ω; 300 Ω; 400 Ω; 500 Ω | |
| RV Pacing Greater than | 1,000 Ω; 1,500 Ω; 2,000 Ω; 3,000 Ω |
Capture Management™ High Threshold
| Parameter | Programmable values | |
|---|---|---|
| High Threshold | RV Capture Enablea | Off; On |
a If programmed to On, alert notification is sent if RV capture management™ has measured high thresholds for 3 consecutive days.
Longevity
Projected Service Life in Years
| Pacing | Pre-arrhythmia EGM storagea | 500 Ω pacing impedance | 600 Ω pacing impedance | 900 Ω pacing impedance | |||
|---|---|---|---|---|---|---|---|
| 2.5 V | 3.5 V | 2.5 V | 3.5 V | 2.5 V | 3.5 V | ||
| VVI, 0% | Off | 18.3 | 18.3 | 18.3 | 18.3 | 18.3 | 18.3 |
| On | 18.2 | 18.2 | 18.2 | 18.2 | 18.2 | 18.2 | |
| VVI, 15% | Off | 17.5 | 16.7 | 17.6 | 16.9 | 17.8 | 17.3 |
| On | 17.4 | 16.6 | 17.5 | 16.8 | 17.7 | 17.2 | |
| VVI, 50% | Off | 15.8 | 13.9 | 16.1 | 14.4 | 16.7 | 15.4 |
| On | 15.7 | 13.8 | 16.0 | 14.3 | 16.6 | 15.3 | |
| VVI, 100% | Off | 13.9 | 11.2 | 14.4 | 11.9 | 15.4 | 13.3 |
| On | 13.8 | 11.1 | 14.3 | 11.8 | 15.3 | 13.2 | |
a The data provided for programming Pre-arrhythmia EGM storage to On are based on a 6-month period (two 3-month follow-up intervals) over the life of the device. Additional use of Pre-arrhythmia EGM storage reduces projected service life by approximately 13.6% or 1.6 months per year.
Note: These projections are based on typical shelf storage time (5 months). Assuming worst-case shelf storage time (18 months), longevity is reduced by approximately 7%.
The data are based on pacing outputs programmed to the specified amplitude and 0.4 ms pulse width and 60 bpm pacing rate. The service life of the device is affected by the programmed settings for certain features, such as Pre-arrhythmia EGM storage. Projected service life estimates are based on accelerated battery discharge data and device modeling as specified. These values should not be interpreted as precise numbers.
Note: Medtronic Azure S SR MRI SureScan W3SR01 Device Manual. M964357A001 B. Accessed September 13, 2017.
Brief Statement
Indications
The Azure DR MRI and Azure SR MRI SureScan™ systems are indicated for rate-adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. Accepted patient conditions warranting chronic cardiac pacing include symptomatic paroxysmal or permanent second- or third-degree AV block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders, or bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias.
The Azure DR MRI devices are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output, VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm, or vasovagal syndromes or hypersensitive carotid sinus syndromes. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications.
MRI Conditions for Use
Medtronic SureScan pacing systems are MR conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. Pacemaker SureScan system patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. A complete SureScan pacing system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com/. Any other combination may result in a hazard to the patient during an MRI scan.
Contraindications
The Azure DR MRI and Azure SR MRI SureScan systems are contraindicated for concomitant implantation with another bradycardia device or with an implantable cardioverter defibrillator. Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms. Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance. ATP therapy is contraindicated in patients with an accessory antegrade pathway.
Warnings and Precautions
Changes in patient's disease and/or medications may alter the efficacy of the device's programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Use of the device should not change the application of established anticoagulation protocols.
Patients and their implanted systems must be screened to meet the following requirements for MRI: no lead extenders, lead adaptors, or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; the device must be operating within the projected service life, and the system must be implanted in the left or right pectoral region.
Potential Adverse Events or Potential Complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. Potential lead complications include, but are not limited to, valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit block. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse.
See the device manuals before performing an MRI Scan for detailed information regarding the implant procedure, indications, MRI conditions of use, contraindications, warnings, precautions, and potential complications. For further information, call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
