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 07/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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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.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported the ipg was unable to communicate with the external devices.Troubleshooting was unable to resolve the issue.The patient underwent an unrelated surgical procedure on (b)(6) 2020 and the ipg was not placed into surgery mode.Surgical intervention may be pending to address this issue.
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Manufacturer Narrative
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The reported observation of ¿no 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 unrelated surgical procedure as stated in the event details.
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Event Description
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Additional information received that patient underwent surgical intervention where in the ipg was explanted and replaced, restoring the therapy.
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Search Alerts/Recalls
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