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 02/01/2022 |
Event Type
Injury
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Event Description
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It was reported the patient lose therapy after a back surgery in (b)(6) 2022.Reportedly, the ipg was not set into surgery mode prior to the surgery, rendering the ipg inoperable.As such, the patient was unable to set the system into mri mode.
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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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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 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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Manufacturer Narrative
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A patient's ipg became inoperable was reported to abbott.The ipg was not set to surgery mode while the patient underwent an unrelated surgical procedure.As a result, the patient¿s ipg was explanted and replaced.Therapy was restored.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.
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Event Description
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Additional information received indicates that surgical intervention took place wherein the ipg was explanted and replaced with a new ipg to address the issue.Reportedly, therapy was confirmed post op.
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Search Alerts/Recalls
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