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 09/17/2019 |
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 patients ipg became inoperable following an unrelated surgery.Troubleshooting was unable to recover the device.
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Event Description
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Follow up information identified the patient did not place the ipg into surgery mode prior to undergoing the unrelated surgeries previously reported.To address the issue, the patient may be awaiting surgical intervention.
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Event Description
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Follow up information identified the patient underwent ipg replacement on (b)(6) 2020, which addressed the issue.
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Manufacturer Narrative
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The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.
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Search Alerts/Recalls
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