Model Number 6660 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 04/29/2019 |
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 the patient underwent an unrelated surgical procedure on (b)(6) 2019.Since the procedure, the patient's ipg has been unable to communicate with their external device due to it being inoperable.Troubleshooting attempts have been unable to provide resolution.As a result, the patient will undergo surgical intervention.
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Event Description
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Further follow-up indicates the patient had surgical intervention on (b)(6)2019, during which the ipg was explanted and replaced.The issue was resolved and therapy has been restored.
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Search Alerts/Recalls
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