Model Number 6662 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problems
Failure of Implant (1924); Movement Disorder (4412)
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Event Date 02/23/2024 |
Event Type
Injury
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Event Description
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It was reported that following an unrelated surgical procedure wherein it is unknown if the device placed into surgery mode, the ipg became unable to communicate with external devices.Troubleshooting has been unable to resolve the issue.As a result, surgical intervention may be undertaken to address the issue.
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Manufacturer Narrative
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Date of event is estimated.
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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 that surgical intervention was undertaken on (b)(6) 2024 wherein ipg was explanted and replaced to address the issue.
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Search Alerts/Recalls
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