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:
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):
For patients where the physician does not believe device explant is the best course of action, Medtronic offers these additional options:
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.
Vice President, Quality, CRHF
Listing of 78 sold device serial numbers in scope of the low resistance path issue by product description:
|Product Name||Models||Serial Numbers|