Model Number 3186 |
Device Problem
Device Remains Activated (1525)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 08/10/2020 |
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: 3006705815-2020-31493, 1627487-2020-33052.It was reported the patient experienced undesired stimulation regardless if therapy was on or off following an mri procedure.As a result, surgical intervention was undertaken on (b)(6) 2020 wherein the ipg was explanted to address the issue.Additional information received indicated the patient underwent surgical intervention on (b)(6) 2020 wherein the leads were explanted to further address the issue.
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Manufacturer Narrative
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The reported uncomfortable stimulation was not confirmed.The lead was returned complete and undamaged.It passed conductivity and stress testing on all channels.When tested with the returned ipg, impedance measurement was in the expected range.No physical or functional anomaly was observed that would contribute to the reported issue.The returned lead displayed normal device characteristics.The root cause of the reported issue could not be conclusively determined.
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Search Alerts/Recalls
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