Model Number 6661 |
Device Problems
Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problems
Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/03/2018 |
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.Manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Manufacturer defers to the patient's physician regarding medical history.
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Event Description
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It was reported the patient's ipg failed to communicate with the clinician programmer.It was unknown if the patient underwent any procedures.Reportedly the patient has stimulation.
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Manufacturer Narrative
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Evaluation codes and description of event were unintendedly incorrect in the initial report.This report contains correct information.
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Event Description
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Additional information gathered identified the patient's ipg failed to communicate with the clinician programmer.Reportedly, the patient has stimulation.
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Search Alerts/Recalls
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