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 06/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.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 patient cannot connect to the ipg with external devices following an unrelated surgery.A manufacturer representative confirmed the issue and the ipg was deemed inoperable.Surgical intervention may be pending to address the issue.
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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.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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