Device product
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
Z-0620-2016
Product summary
- Event
- Event 72855
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-0620-2016
Official wording
Reason: The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
Code information: Serial numbers 702961, 702963, 705644, 705666, and 705947.
Distribution pattern: International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.
Derived failure modes
-
Unknown
The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.