Model Number 3346 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 03/20/2016 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.During processing of this complaint, attempts were made to obtain complete event information.
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Event Description
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Reference manufacturer report number: 1627487-2019-11483, reference manufacturer report number: 1627487-2019-11485.It was reported that the patient was not receiving adequate therapy with their scs system.The patient underwent a laminectomy which removed all their pain.The ipg and extensions were explanted and the leads were left in place.It is unknown when the ipg and extensions were explanted.
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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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