Model Number 3186 |
Device Problem
Disconnection (1171)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 12/08/2019 |
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: 3006705815-2020-00981, 1627487-2020-02323.It was reported that the patient experienced shocking and painful stimulation.As a result, patient was hospitalized in (b)(6) 2019 (exact date unknown).X-rays showed that the patient's leads had disconnected from the ipg.Surgical intervention may be pending to address the issue.
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Manufacturer Narrative
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Patient weight was added.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 the entire system was explanted and replaced with a new ipg and two new leads.Post-operatively, stimulation therapy was restored.
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Search Alerts/Recalls
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