Model Number 3383 |
Device Problem
Disconnection (1171)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 10/25/2019 |
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 numbers: 1627487-2019-12795, 3006705815-2019-04456.It was reported that the patient experienced ineffective stimulation on their right side.X-rays were taken that showed one of the lead extensions had pulled out of the ipg header.In turn, surgical intervention may be pending to address this issue.It is unknown which lead extension pulled out, therefore both lead extensions are being reported.
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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 stated that the patient underwent surgical intervention wherein both extensions were explanted and replaced with longer extensions.Post-operatively, stimulation therapy was restored.
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Search Alerts/Recalls
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