Model Number 3662 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 03/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Event date is an estimate.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 the patient underwent a non-related surgical procedure wherein the ipgs were not placed into surgery mode prior to the procedure.As a result, the patient's ipgs were unable to communicate with external devices and the patient lost therapy.A manufacturer representative confirmed the issue and the ipgs were deemed inoperable.Surgical intervention may occur at a later date to address the issue.
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Manufacturer Narrative
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An 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.Based on the information received, the cause of the reported incident is consistent with user error.
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Manufacturer Narrative
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An 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.Based on the information received, the cause of the reported incident is consistent with user error.
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Event Description
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Additional information received indicates the patient¿s ipg was explanted and replaced on (b)(6) 2022 resolving the issue.
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Search Alerts/Recalls
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