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 08/03/2022 |
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 had an unrelated surgery where the device was not placed in 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 took place wherein the ipg was explanted and replaced.
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Event Description
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Additional information received indicates effective stimulation has been restored.
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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.Effective stimulation 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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Search Alerts/Recalls
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