Model Number 3662 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 10/19/2022 |
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 underwent an unrelated surgical procedure.Patient did not set the ipg into surgery mode as recommended.Thereafter, the ipg failed to establish communication with external device.Recovery efforts were unsuccessful and the ipg was deemed inoperable.Patient is not receiving therapy and may require surgical intervention to address the issue.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Actions have been taken to prevent reoccurrence.
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Event Description
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Additional information was received that the patient's ipg was explanted and replaced.Effective therapy was established post operatively.
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Manufacturer Narrative
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During processing of this incident, attempts were made to obtain patient weight.Further information was requested but not received.
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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.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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Search Alerts/Recalls
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