Model Number 3660 |
Device Problem
Premature Elective Replacement Indicator (1483)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/30/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The method, results, and conclusion codes will be sent in a subsequent report once investigation is complete.The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.
|
|
Event Description
|
It was reported the wireless software update was performed clearing the elective replacement indicator (eri) message.The device is providing therapy.
|
|
Manufacturer Narrative
|
A system displaying the ¿replace generator soon¿ message was reported to abbott.The device was not returned for analysis; however, event details indicate that the system was updated to resolve the issue.Actions have been taken to prevent reoccurrence.
|
|
Search Alerts/Recalls
|