Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Recall
- Recall Number
- Z-0239-2020
- Event Number
- 84026
- Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- FEI Number
- 2182208
- Product Code
- OSR
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 3, 2019
- Address
- 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391
Description
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.
In the US, beginning 03-Oct-2019, Medtronic field representatives bean notifying the consignees. A Medical Device Correction Letter will be provided to Follow-up physicians with affected patients. Hospital Risk Managers of accounts that, according to Medtronic records, have affected devices, programmers and remote monitoring systems will receive a courtesy notification. The firm notified the physicians by letter on 10/07/2019 of the issue with the programmer and recommended the following patient management recommendations: Prophylactic device replacement is not recommended, as device functionality and the RRT indicator are not impacted by the inaccurate longevity estimate. Until the software update becomes available: -Continue normal patient follow-up in accordance with standard practice. -Per labeling, continue to use the RRT notification to identify when device replacement should be scheduled. Where available, utilize the low battery voltage RRT audible alert or wireless CareAlert. -At any time, if a lower-than-expected remaining longevity estimate occurs, contact Medtronic Technical Services for assistance additional analysis of stored device information will be required to assess if the decreased longevity estimate is due to this issue.
Worldwide Distribution
29544 units