Model Number 3662 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 07/11/2019 |
Event Type
malfunction
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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.Date of event is estimated.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 following an unrelated surgery in which the system was not put into surgery mode as recommended, the ipg would not communicate with external devices.Surgery may occur to address the issue.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain patient weight, but it could not be obtained.
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Search Alerts/Recalls
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