Model Number 3662 |
Device Problems
Device Inoperable (1663); Communication or Transmission Problem (2896)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 11/21/2017 |
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 that the thoracic scs ipg was unable to communicate with the external devices after the cervical ipg was implanted ((b)(6) 2017).Troubleshooting was attempted to no avail and the ipg was inoperable.
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Event Description
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Additional information identified that surgical intervention may be undertaken at a later date to address the issue of inoperable ipg.
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Event Description
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Additional information identified that ipg was explanted and replaced in the same ipg pocket.
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Search Alerts/Recalls
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