Model Number 3788 |
Device Problems
Nonstandard Device (1420); No Device Output (1435)
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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's scs ipg was inoperable (date of event unknown).A sjm representative confirmed the communication issue by using multiple external devices.Surgical intervention was taken where the ipg was explanted and replaced with another model.
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Event Description
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Additional follow up identified the issue has resolved through surgical intervention.Reportedly, therapy was restored postoperatively.
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Search Alerts/Recalls
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