Model Number 3789 |
Device Problems
Charging Problem (2892); Unintended Movement (3026)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 06/05/2014 |
Event Type
Injury
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Event Description
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Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2015, where the ipg was explanted and replaced.
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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 is experiencing difficulty charging her ipg after implant.It was also reported, the patient's ipg is loose in the pocket and the patient has to reposition the ipg in the pocket to charge.As a result, the patient is unable to maintain therapy.The patient will consult with the physician regarding surgical intervention as the next course of action.
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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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