Model Number 3660 |
Device Problems
Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/31/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on (b)(6) 2017.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 the ipg could not communicate with external devices following an unrelated surgery in (b)(6) 2019.Troubleshooting was unable to resolve the issue.Surgical intervention may be pending at a later date.
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Manufacturer Narrative
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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 incident could not be conclusively determined.
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Event Description
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Additional information indicates surgical intervention was undertaken on (b)(6) 2020 wherein the ipg was explanted and replaced.Issue resolved.
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Search Alerts/Recalls
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