Model Number 3788 |
Device Problems
Failure to Charge (1085); Nonstandard Device (1420); Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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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.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 not recharged the system in months (event date is unknown).Reportedly, the patient encountered difficulty charging in addition, the ipg would no longer communicate with any external devices.A replacement charger was sent to no avail.Surgical intervention may be undertaken as the next course of action.
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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.
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Event Description
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Follow-up identified the issue is resolved.
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Search Alerts/Recalls
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