Model Number 3660 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Date 12/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Event date 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.
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Event Description
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It was reported the patients ipg became inoperable following an unrelated surgery.Surgery mode was not enabled on patient controller.Surgical intervention may take place at a later date.
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Manufacturer Narrative
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Correction: b1 - report type should have been both adverse event and product problem.Correction: h1 - type of reportable event should have been serious injury.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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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.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 indicated that surgical intervention was undertaken wherein the ipg was explanted and replaced.Stimulation was restored.
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Search Alerts/Recalls
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