Model Number 3660 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 09/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on (b)(6) 2017.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Actions have been taken to prevent reoccurrence.
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Event Description
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It was reported the patient underwent a non-related surgical procedure wherein the ipg was not placed into surgery mode prior to the procedure.As a result, the patient's ipg was unable to communicate with external devices and the patient lost therapy.A manufacturer representative confirmed the issue and the ipg was deemed inoperable.In turn, the patient underwent surgical intervention wherein the ipg was explanted and replaced to address the issue.
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Manufacturer Narrative
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The reported event for inoperable ipg was confirmed.It was determined the device was running the service application software.This condition is consistent with electrocautery use during surgery.Per event details, the ipg no longer communicated following an unrelated surgery.There is guidance in the clinicians manual regarding proper handling of the device when using electrocautery.As a result of this finding, actions have been taken to prevent reoccurrence.
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Search Alerts/Recalls
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