Model Number 3186 |
Device Problem
High impedance (1291)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Date 11/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.Further information was requested but not received.
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Event Description
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Related manufacturer reference number: 3006705815-2021-04628.It was reported the patient experienced autoreducing causing ineffective stimulation.Diagnostics indicated high impedances.In turn, the system was explanted and replaced 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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Search Alerts/Recalls
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