Model Number 3341 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 09/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference number: 1627487-2019-11512, 1627487-2019-11513, 1627487-2019-11514, 1627487-2019-11515.It was reported the patient experienced ineffective stimulation.Surgical intervention may take place at a later date.
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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 indicates the patient¿s system was explanted.
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Search Alerts/Recalls
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