Model Number 3788 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
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.(b)(4).
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Event Description
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It was reported the patient last charged the ipg in (b)(6) 2015 (date of event is unknown).The patient also last experienced stimulation around that time.The sjm representative confirmed the ipg was unable to communicate with external devices.Surgical intervention will take place to address the issue.
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Event Description
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Follow-up identified the patient underwent surgical intervention to explant and replace the ipg.Stimulation was restored following the surgical intervention.
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Search Alerts/Recalls
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