Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle Spasm(s) (1966); Inadequate Pain Relief (2388)
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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.
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Event Description
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Device 2 of 2: reference mfr.Report# 1627487-2016-04269.It was reported the patient experienced ((b)(6)) ineffective stimulation along with muscle contraction with stimulation.X-rays revealed the left lead has migrated toward the right side.Surgical intervention is planned to address the issue.It is unknown which one is the left lead.Therefore, all the suspected devices are being reported.
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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# 1627487-2016-04269.Additional follow up received identified the leads were explanted and replaced which resolved the issue.Reportedly, effective stimulation was restored postoperatively.
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Search Alerts/Recalls
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