Model Number 3788 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 04/27/2014 |
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 charging system has been unable to communicate with her ipg.In turn, the programmer has been unable to communicate with the ipg due to it being inoperable.It was also reported the patient feels the ipg is no longer stationary within the pocket.As a result, the patient will undergo surgical intervention.
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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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Follow-up revealed the patient's ipg was explanted and replaced.
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Search Alerts/Recalls
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