Model Number 3662 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 06/14/2018 |
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.The 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.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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It was reported the ipg was unable to communicate with the external device.The patient recently underwent surgery and did not place the ipg into surgery mode.Troubleshooting was unable to resolve the issue and an abbott representative confirmed the issue.Surgical intervention may be pending to address the issue.
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Event Description
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Follow up information identified preoperatively, the ipg was unable to communicate with the external device and this was confirmed by the abbott representative.The patient underwent surgical intervention on (b)(6) 2018 where the ipg was removed and replaced.Postoperatively, effective therapy was established.
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Search Alerts/Recalls
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