Model Number 3662 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 05/01/2018 |
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 lost communication with the ipg after undergoing an unrelated hip replacement surgery on (b)(6) 2018.The patient¿s ipg was not put in surgery mode prior the procedure.It was confirmed that electrocautery was used during the procedure.Troubleshooting was unable to resolve the issue.Surgical intervention may be pending to address the issue.
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Event Description
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Follow up information identified the patient's ipg was replaced with a new one resolving the issue.
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Search Alerts/Recalls
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