Model Number 3788 |
Device Problems
Device Stops Intermittently (1599); Low impedance (2285)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 03/12/2015 |
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.
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Event Description
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It was reported the patient (b)(6) experienced intermittent stimulation as the ipg was turning off spontaneously.System diagnostics determined low impedances on some contacts.A sjm representative reprogrammed the patient avoiding those contacts.Later, surgical intervention was taken where the ipg was explanted and replaced with another model.
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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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Search Alerts/Recalls
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