|
Model Number 53401 |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that during normal use, the external pulse generator (epg) would reset to nominal settings.The epg is expected to be returned, but its current status is unknown.There was no patient involvement.
|
|
Manufacturer Narrative
|
Product analysis: manufacturer's analysis confirmed the customer comment that the external pulse generator (epg) would reset to nominal settings.A firmware update was required to resolve the issue.It was also indicated that a cover was broken.The epg was repaired and returned to service.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|