Model Number 3662 |
Device Problems
Premature Elective Replacement Indicator (1483); Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that the elective replacement indicator (eri) message displayed for the ipg.It is unknown if the ipg depleted prematurely.Troubleshooting may be pending to address the issue.
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Manufacturer Narrative
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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 of the investigation are inconclusive, since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Actions have been taken to prevent reoccurrence.
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Event Description
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Additional information received, indicated that a wireless software update was performed, clearing the elective replacement indicator (eri) message.
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Search Alerts/Recalls
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