Model Number 3662 |
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 06/28/2022 |
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 02 june 2017.
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Event Description
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It was reported that the patient was unable to communicate with their ipg following an unrelated procedure.Reportedly, the ipg was not set into surgery mode.Troubleshooting was unable to resolve the issue.As such, surgical intervention may take place 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.As a result, the patient¿s ipg was explanted and replaced.Therapy was restored.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 that surgical intervention took place on
(b)(6) 2022 where in the ipg was explanted and replaced with a new ipg addressing the issue.Reportedly, effective therapy was confirmed post-op.
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Search Alerts/Recalls
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