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 07/01/2021 |
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.
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Event Description
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It was reported that the patient underwent an unrelated neck surgery approximately on (b)(6) 2021 and surgery mode was not turned on prior to the procedure.Following the procedure, the ipg would not communicate with external devices.No further information available.
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Manufacturer Narrative
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N inoperable implant was reported to abbott.The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used.The implant was not returned for analysis.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.
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Manufacturer Narrative
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H1: is changed from malfunction to serious injury.
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Event Description
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Additional information received indicated patient underwent surgical intervention wherein the ipg was replaced and reportedly effective therapy was restored.
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Manufacturer Narrative
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The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used.The implant was not returned for analysis.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Based on the information received, the cause of the reported incident is consistent with user error.
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Search Alerts/Recalls
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