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 05/12/2021 |
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 02 june 2017.During processing of this complaint, attempts were made to obtain complete patient information.
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Event Description
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It was reported that the patient's ipg stopped communicating with external devices following an unrelated hip surgery where surgery mode was not enabled.A manufacturer representative met with the patient and deemed the ipg to be inoperable.Surgical intervention may take place at a later date to address the issue.
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Manufacturer Narrative
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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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A4 patient weight added to the report.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 stated that the patient underwent surgical intervention wherein the ipg was explanted and replaced.Post-operatively, stimulation therapy was restored.
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Search Alerts/Recalls
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