Product defect correction / Implant hazard alert: ACCOLADE dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps)

Boston Scientific have advised that a subset of ACCOLADE™ dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST™ cardiac resynchronization therapy pacemakers (CRT-Ps) have an increased risk of permanently entering Safety Mode which has limited functionality.

Affected Model numbers: L311, L331, U225, U226, U228

Product Names:

• ACCOLADE DR SL MRI
• ACCOLADE DR EL MRI
• VISIONIST CRT-P EL
• VISIONIST CRT-P EL MRI

What is the problem?

Affected devices are at risk of permanently entering Safety Mode during telemetry or other normal, higher-power operations. This has been associated with the pacemaker failing to adequately regulate the heart’s rhythm and rate in some patients.

What are the risks?

Risks associated with this problem occurring include:

• Device replacement/surgery being required
• Loss or pause of pacing activity that may result in death or serious injury in some patients not sufficiently treated by Safety Mode
• Muscle stimulation
• Heart failure.

What should patients do?

• Continue to have your device monitored, either remotely or through your existing in-office follow-up schedule.
• If monitoring indicates your device has entered Safety Mode, immediately contact your treating clinician for a review and to discuss management options.
• Also consult with your treating clinician if you:
  • have new or worsening symptoms such as light-headedness, chest pain, shortness of breath, palpitations, dizziness or loss of consciousness
  • have any questions about your device potentially entering Safety Mode or
  • to determine the remaining battery life and whether or not the problem may affect you.
• Should you be experiencing symptoms and unable to contact your clinician we recommend attending your nearest healthcare facility for assessment.

What should health professionals do?

• Monitor patients with affected pacemakers through remote or in-person visits.
• When a device is in Safety Mode, you will be directed to contact Boston Scientific via the LATITUDE programmer warning screen and a LATITUDE remote patient management system red alert.
• Monitor patients for symptoms indicating device performance problems, such as light-headedness or loss of consciousness.
• General prophylactic device replacement is not recommended: unless a patient has a device in the advisory population and are at risk of harm due to non-programmable parameters in Safety Mode.
• If monitoring indicates that the device has entered Safety Mode, arrange for the device to be replaced. Timely replacement is recommended to avoid risks associated with time spent in Safety Mode.
• Detailed information can be found in the customer letter supplied to clinicians who have implanted this device.

The problem with these devices will be corrected by a software update. Boston Scientific will communicate when the update is available to detect the onset of a high impedance battery state.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.