Model Number 3661 |
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 12/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.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.
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Event Description
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It was reported that the patient's ipg was unable to communicate with external devices after an unrelated surgery.A manufacturer representative confirmed the issue and the ipg was deemed inoperable.Generator logs were assessed and also confirmed that the ipg was not communicating.Surgical intervention may be pending to address the issue.
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Event Description
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Additional information received stated that the patient's ipg was explanted and replaced on (b)(6) 2019.Post-operatively, stimulation therapy was restored.
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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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