Model Number 3660 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 10/01/2017 |
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¿s ipg became inoperable after undergoing surgery for an unrelated issue in (b)(6) 2017.It is unknown if the patient¿s ipg was put into surgery mode prior to the procedure.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 restoring therapy.
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Search Alerts/Recalls
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