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 08/27/2019 |
Event Type
malfunction
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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 that patient¿s ipg failed to established communication with external devices after a cervical surgery.Reportedly, the ipg was not set into surgery mode during the procedure.Field representative was able to recover connection after troubleshooting.Issue has been resolved.
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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.Actions have been taken to prevent reoccurrence.
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Search Alerts/Recalls
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