Model Number 3608 |
Device Problem
Low Battery (2584)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/28/2015 |
Event Type
Injury
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Event Description
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It was reported, the patient ((b)(6)) received an ipg "low battery" notification earlier than expected.The ipg was explanted and replaced with a different model ipg.The patient now receives effective stimulation therapy.
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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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Results: electrical pulse load testing of the ipg battery confirmed the low battery indication observed in the field was due to the ipg battery having passivated.Once the passivation was cleared the ipg low battery indication did not appear during ipg battery pulse load testing.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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