Model Number 3660 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 07/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.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's ipg became inoperable, following an unrelated medical procedure.It was also reported that the device was not placed in surgery mode prior to the surgery.As a result, the patient may undergo surgical intervention at a later date.
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Event Description
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Additional information received stated that the patient underwent surgical intervention wherein the ipg was explanted and replaced.Post-operatively, stimulation therapy was restored.
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Manufacturer Narrative
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The analysis results concluded the communication and stimulation from the implantable pulse generator (ipg) appeared to be normal up to the reported unrelated procedure date.The root cause of the observation was due to the device entering the service application state.
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Search Alerts/Recalls
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