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 07/10/2019 |
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 in the final report.
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Event Description
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It was reported the patient underwent an unrelated surgical procedure.Since the procedure, the patient's ipg has been unable to communicate with the external device due to it being inoperable.Troubleshooting attempts have been unable to provide resolution.As such, the patient will undergo surgical intervention to address the issue.
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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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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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Manufacturer Narrative
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Correction: device available for evaluation; device evaluated by manufacturer.
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Search Alerts/Recalls
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