Merlin PCS 3650 programmer Model 3330 software
Recall
- Recall Number
- Z-1495-2022
- Event Number
- 90530
- Firm
- St. Jude Medical, Cardiac Rhythm Management Division
- FEI Number
- 2017865
- Product Code
- DXY
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- June 17, 2022
- Address
- 15900 Valley View Ct, Sylmar, CA, 91342-3577
Description
Merlin PCS 3650 programmer Model 3330 software
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
On June 16, 2022 Abbott issued a "Medical Device Correction" via: XXXX to affected consignees. The customer notification ask consignees to take the following action: 1. Prophylactic device replacement is not recommended, as device functionality, actual longevity, and ERI indicator are not impacted (device functionality remains normal and within specifications). 2. Routine follow-up should remain as per local standard of care and clinical protocol, and ERI should continue to serve as an indicator of the need for device replacement scheduling. 3. Please direct any questions about device longevity to Abbott Technical Support at 1-800-722-3774 (U.S.). 4.Upon programmer software / remote monitoring software update, the improved longevity estimate will be displayed at the patient s next interrogation. Please note that until programmers are updated, a difference in longevity estimates between programmers and remote monitoring (Merlin.net) may be observed.
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