Model Number 3186 |
Device Problems
Low impedance (2285); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/24/2020 |
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: 3006705815-2021-00585.It was reported the patient experienced ineffective stimulation after a fall.Diagnostics showed low impedances on the leads.As a result, surgical intervention may be pending.
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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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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 indicates the system was explanted and replaced to address the issue.
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Search Alerts/Recalls
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