Model Number 3771 |
Device Problems
Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/01/2019 |
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 on the final report.
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Event Description
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It was reported that the patient experienced a loss of therapy following an unrelated surgery.As a result, surgical intervention was taken to explant and replace the ipg.Issue has been resolved.
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Manufacturer Narrative
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This event was inadvertently assigned to 1627487-060217-001-c.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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