Model Number 3788 |
Device Problems
Nonstandard Device (1420); No Device Output (1435); Use of Device Problem (1670); Device Displays Incorrect Message (2591)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 11/06/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This ipg serial number was included in a field advisory.1627487-07262012-002-r.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.Udi(di): (b)(4).
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Event Description
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It was reported the patient has been without stimulation for an undetermined amount of time.Reportedly, the ipg became inoperable after the patient had an unrelated surgery 4-5 months ago during which time the system was turned off and has not been recharged.It's unknown when the patient last recharged.Subsequently, the ipg will no longer communicate with any external devices and the patient programmer displays a communication error message.Surgical intervention may be undertaken as the next course of action to address 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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Event Description
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Follow-up identified surgical intervention was undertaken on (b)(6) 2015.The ipg was explanted and replaced which resolved the issue.
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Search Alerts/Recalls
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