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 06/01/2022 |
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 the patient lost stimulation because ipg could not communicate with external devices following an unrelated surgery and ipg was not put into surgery mode.Subsequently, the patient has been unable to connect to the ipg.Troubleshooting was attempted by the company representatives to no avail.Surgical intervention may take place at a later date.
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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 rep replied via e-mail that patient has elected to try injections before replacing stimulator.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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