Model Number 3660 |
Device Problems
No Apparent Adverse Event (3189); Wireless Communication Problem (3283)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2023 |
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 02 june 2017.
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Event Description
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It was reported that following an unrelated surgical procedure where the device was not placed into surgery mode, the ipg became unable to communicate with external devices.Troubleshooting has been unable to resolve the issue.Surgical intervention may be undertaken at a later date to address the issue.
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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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Manufacturer Narrative
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E1 correction: the reporter's information was updated.
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Event Description
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Additional information was received after cp logs were provided.Analysis indicated that the ipg had not entered into a bondable state and the ipg had reached end of life, meeting longevity.This is no longer reportable.
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Search Alerts/Recalls
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