Model Number 3662 |
Device Problem
Premature Elective Replacement Indicator (1483)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/28/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.The results/method and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
It was reported that the elective replacement indicator (eri) triggered earlier than intended.The wireless software update was performed clearing the eri message.The device is providing therapy.
|
|
Manufacturer Narrative
|
During processing of this complaint, attempts were made to obtain complete patient information.
|
|
Search Alerts/Recalls
|