Model Number 3688 |
Device Problems
Device Stops Intermittently (1599); Low Battery (2584)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 04/09/2015 |
Event Type
Injury
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Event Description
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It was reported the patient's ipg was prompting "low battery warning" and the device stops intermittently.A sjm representative tried troubleshooting to no avail.Gradually, the patient lost stimulation.Surgical intervention will be taken at a later date to address the issue.
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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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Further follow up identified the ipg was explanted and replaced with a different model which resolved the issue.
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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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