Model Number 3788 |
Device Problems
Nonstandard Device (1420); Device Inoperable (1663)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 12/30/2015 |
Event Type
Injury
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Manufacturer Narrative
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This ipg serial number was included in a field advisory.(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.(b)(4).
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Event Description
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It was reported the patient ipg was inoperable.Subsequently, the patient underwent surgical intervention on (b)(6) 2015, where the ipg was explanted and replaced.
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Event Description
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Follow-up information revealed the patient last recharged her ipg approximately a month ago.In addition, the patient last had stimulation therapy approximately 2 weeks prior to the procedure.It was also noted the patient recharged the device as instructed.
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Search Alerts/Recalls
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