Model Number 6662 |
Device Problem
Battery Problem (2885)
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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 10/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.During processing of this incident, attempts were made to obtain complete event and device information.Further information was requested but not received.
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Event Description
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It was reported that the patient¿s ipg is nearing end of life.It is unknown if this occurred prematurely.As such, 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 incident could not be conclusively determined.During processing of this incident, attempts were made to obtain complete event and device information.Further information was requested but not received.
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Search Alerts/Recalls
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