Model Number 3660 |
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 09/10/2019 |
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 that patient underwent an unrelated surgical procedure.Prior to the procedure, patient did not set the ipg into surgery mode as recommended.Thereafter, the ipg failed to establish communication with external devices.
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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.Actions have been taken to prevent reoccurrence.
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Event Description
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Additional information received identified that the ipg was successfully recovered with the clinician programmer.
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Search Alerts/Recalls
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