Model Number 3662 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 05/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.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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It was reported the patient was unable to communicate with the ipg following an unrelated hip replacement procedure.At this time, the next course of action is yet to be determined.
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Event Description
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Follow-up identified additional troubleshooting was attempted by the field representative; however, communication could not be established with the ipg.
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Event Description
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Follow-up identified the patient's ipg was not placed in surgery mode prior to hip surgery.Surgical intervention was undertaken on (b)(6) 2018 to explant and replace the ipg.Stimulation was re-established following the procedure.
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Search Alerts/Recalls
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