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 07/16/2019 |
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.Investigation results will be provided in the final report.Event date is an estimation.
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Event Description
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It was reported that the patient's ipg was inoperable.The patient had shoulder surgery in (b)(6) 2019.Following the procedure, the ipg would not communicate with external devices.As a result, surgical intervention is anticipated in the future.
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Event Description
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It was reported that the patient's ipg was explanted and replaced on (b)(6) 2019.Therapy has not yet been restored.
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Event Description
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Additional information received indicated the patient is reportedly receiving effective therapy.
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Search Alerts/Recalls
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