Model Number 3662 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Date 05/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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It was reported the patient's ipg failed to establish communication with external devices.A manufacturer representative confirmed the issue and the ipg was deemed inoperable.In turn, surgical intervention may take place 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 event could not be conclusively determined.
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Event Description
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Additional information received indicated the patient underwent surgical intervention wherein the ipg was explanted and replaced to address the issue.
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Search Alerts/Recalls
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