Device product
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
Z-2749-2016
Product summary
- Event
- Event 74812
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-2749-2016
Official wording
Reason: Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.
Code information: serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.
Distribution pattern: Distributed to the states of TX, NH, MA, PA, and MN.
Derived failure modes
-
Unknown
Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.