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 07/11/2022 |
Event Type
Injury
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Event Description
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It was reported that following an unrelated surgical procedure where the ipg was not placed into surgery mode, the ipg became unable to communicate with external devices.Troubleshooting was unable to resolve the issue.As a result, surgical intervention may be undertaken in the future.
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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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Event Description
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Additional information indicates surgical intervention was undertaken on (b)(6) 2022 wherein the ipg was explanted and replaced to address the issue.
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Manufacturer Narrative
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The reported observation of ¿ipg communication¿ was confirmed.The analysis results concluded the inability to establish communication between the programmer and the implantable pulse generator (ipg) was due to the device entering the service application state.The root cause of the device entering the service application state was due to the patient¿s surgical procedure.Per the clinicians manual arten600266417 warnings - electrosurgery.To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems.Before using an electrosurgery device, place the device in surgery mode using the patient controller app or clinician programmer app.Confirm the neurostimulation system is functioning correctly after the procedure.Under warnings - there is sufficient documentation concerning the use of use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system, and medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).
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Search Alerts/Recalls
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