Model Number 3660 |
Device Problems
Battery Problem (2885); Wireless Communication Problem (3283)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Date 12/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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Event date is an estimate.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 underwent a non-related surgical procedure wherein the ipg was not placed into surgery mode prior to the procedure.As a result, the patient's ipg was unable to communicate with external devices and the patient lost therapy.Additional troubleshooting is pending to interrogate the ipg.
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Event Description
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Additional information received indicated that a company representative was able recover the ipg through troubleshooting.Effective therapy was re-established.
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Manufacturer Narrative
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An inoperable pulse generator 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 system was recovered through abbott intervention.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.The results of the investigation are inconclusive since the device was not returned for analysis.Actions have been taken to prevent reoccurrence.
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Manufacturer Narrative
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H6: changed from 2885 - battery problem to 3283 - wireless communication problem, added 1924 - failure of implant.
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Search Alerts/Recalls
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