Model Number 3383 |
Device Problem
Disconnection (1171)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 4 of 4: reference mfr.Report: 1627487-2018-08015; reference mfr.Report: 3006705815-2018-02042; reference mfr.Report: 1627487-2018-08016.It was reported the patient presented to the emergency room due to an unpleasant sensation at the ipg pocket site.The patient has a history of strokes and has fallen multiple times in the past.Surgical intervention was undertaken on (b)(6) 2018.During the procedure, it was noted the lead had pulled out of the extension.The ipg was explanted and replaced.The reported extensions were explanted.Effective stimulation was restored post-operatively.
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Event Description
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Device 4 of 4 : reference mfr.Report: 1627487-2018-08015 ; reference mfr.Report: 3006705815-2018-02042 ; reference mfr.Report: 1627487-2018-08016.
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Search Alerts/Recalls
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