Model Number 3383 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this incident, attempts were made to obtain complete event information.
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Event Description
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Related manufacturer reference number: 1627487-2021-16694.Related manufacturer reference number: 1627487-2021-16695.Related manufacturer reference number: 1627487-2021-16696.It was reported patient had loss of therapy due to the ineffective coverage of dual occipital and dual supra orbital system.Images indicated that the dual extension were kinked and fractured.As a result, surgical intervention took place wherein the ipg and one extension was explanted and replaced with new ones.Post operatively effective stimulation was restored.
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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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