Model Number 3688 |
Device Problem
Low Battery (2584)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 05/23/2015 |
Event Type
malfunction
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Event Description
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Follow-up identified surgical intervention was undertaken on (b)(6) 2015 during which time the ipg was explanted and replaced with a different model.Effective therapy was restored postoperatively.The issue is resolved.
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Event Description
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It was reported the patient received a low battery warning on the patient programmer.Diagnostic testing revealed low impedance values.No further information is available on the next course of action at this time.
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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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Manufacturer Narrative
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The report number was inadvertently entered incorrectly.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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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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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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