Model Number 3788 |
Device Problems
Charging Problem (2892); Unintended Movement (3026)
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Patient Problems
Inadequate Pain Relief (2388); Weight Changes (2607)
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Event Date 02/18/2015 |
Event Type
Injury
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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 post-operatively.
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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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It was reported, the patient ((b)(6)) gained weight and the scs ipg appeared to be tilted in the ipg pocket.As a result the patient was unable to establish communication between ipg and external devices.A sjm representative tried trouble shooting to no avail.Surgical intervention will be taken at a later date to address the issue.
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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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Search Alerts/Recalls
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