Urgent Medical Device Correction

For a subset of Viva™ Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Evera™ Implantable Cardioverter Defibrillators (ICDs)

August 2016

Dear Physician,

Medtronic is writing to inform you about an issue with 78 Viva™ CRT-Ds and Evera™ ICDs that were manufactured with a specific subset of circuit components (see appendix A for a listing of affected devices). Devices in the affected population may experience rapid battery depletion due to a low resistance path developing within the circuit component. This is not related to a failure within the battery. Based on our records, an estimated 53 of these 78 devices remain active.

Development of a low resistance path in the circuit component in some cases has been reported to cause battery depletion in seven (7) days or less and may present clinically during a patient follow-up visit as:

• One or more electrical resets, which will display as an observation on the programmer.
• No pacing or defibrillation therapy output.
• No telemetry.
• Programmer screen display of “SERIOUS DEVICE MEMORY FAILURE.”

Patient audible alerts and CareAlerts™ may not reliably notify the patient or clinician, due to this issue.

Within these 78 devices there have been seven (7) confirmed failures (9%) through July 16, 2016. Medtronic modeling predicts an additional six (6) failures may occur in the remaining active population. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant. No deaths have been reported related to this issue.

Medtronic records indicate you are following one or more patients with an affected device. Please see the enclosed Physician/Patient Detail Report for a listing of your patients and their affected device serial numbers.

Patient Management Recommendations
We realize that each patient requires unique clinical consideration and we support your judgment in caring for your patients. After consultation with Medtronic’s Independent Physician Quality Panel, Medtronic offers the following options for managing patients implanted with an affected device:

Advise patients to seek medical attention immediately if they experience symptoms (e.g., fainting or lightheadedness) or if the audible patient alert sounds.

For pacemaker-dependent patients or those at a higher risk of Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF):

• Physicians should consider device replacement.

For patients where the physician does not believe device explant is the best course of action, Medtronic offers these additional options:

• Program the audible alerts for “Low Battery Voltage RRT” to “On-High”. It is possible that alerts may notsound if the battery is depleted. Therefore physicians should also consider one of the following:
  • Provide a handheld magnet to patients to frequently check device status.
    • Requires one or more audible alerts be programmed ON.
    • Device operation may be monitored frequently (e.g., daily) by patients placing the magnet over the device for 1-2 seconds and then removing the magnet. If the device is functional, a steady tone will sound for approximately 10 seconds. If no tone or an oscillating high/low tone is heard, advise patients to seek care immediately.
      
      
  • Prescribe either a CareLink™ transmission be performed by the patient, or a maintenance transmission by the clinic, on a more frequent basis (e.g., weekly or daily) based on the unique patient considerations. The clinic should review these transmissions upon receipt.
    • If the transmission is unsuccessful the patient should be brought into the clinic for immediate follow-up as this may be an indication that the device battery has depleted to a level where it can no longer support telemetry.
    • Review transmissions for any signs of this issue (e.g., one or more electrical resets, or notification that a device alert has occurred).
    • Each transmission will decrease battery longevity by approximately one day.

Medtronic will notify all applicable regulatory agencies about this matter. Please share this notification with others in your organization as appropriate.

Medtronic will offer a supplemental device warranty if the device is not already at elective replacement. Contact your sales representative for terms and conditions.

We sincerely regret any difficulties this may cause you and your patients. Medtronic remains dedicated to patient safety and will continue to monitor device performance to ensure we meet your needs and those of your patients. Medtronic Patient Services is available to assist patients at 800-551-5544.

If you have any questions, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Sincerely,

Tim Samsel
Vice President, Quality, CRHF
Medtronic