Model Number 3660 |
Device Problem
Battery Problem (2885)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Date 09/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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Event date is estimated.
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Event Description
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It was reported the patient¿s ipg was unable to communicate with external devices.A manufacturer representative confirmed the issue and the ipg deemed inoperable.Surgical intervention may be taken 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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Event Description
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Additional information received reports that the patient had his scs ipg replaced on (b)(6) 2021 because the ipg was inoperable.Stimulation therapy was reportedly restored postoperatively.
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Search Alerts/Recalls
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