Model Number 3662 |
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 04/25/2019 |
Event Type
malfunction
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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's ipg was unable to communicate with external devices.The patient underwent a non-related surgical procedure wherein the device was not placed into surgery mode prior to the procedure.
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Event Description
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Additional information received indicated that the patient underwent surgical intervention on (b)(6) 2019 wherein the ipg was explanted and replaced.Therapy was established post-op.
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Search Alerts/Recalls
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