Model Number 3186 |
Device Problem
Cut In Material (2454)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 09/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.(b)(4).
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Event Description
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Device 2 of 2: reference mfr.Report: 1627487-2016-04994.It was reported during the patient's ipg revision procedure (reference mfr.Report: 1627487-2016-05095) , the physician inadvertently severed one of the leads, rendering it unusable.As a result, the patient currently has ineffective left-side stimulation.Surgical intervention is planned to address the issue.
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Manufacturer Narrative
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Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Device 2 of 2.Reference mfr.Report: 1627487-2016-04994.Follow-up identified the patient underwent surgical intervention to explant and replace the affected lead.
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Search Alerts/Recalls
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