InjuryLQW
QUATTRODE
Received Sep 24, 2012 · Event occurred Sep 5, 2012
Report 1627487-2012-02377 · MDR key 2762476
Device
Product problems
- Migration or Expulsion of Device
- Device Operates Differently Than Expected
Patient
49 YR
- Inadequate Pain Relief
Narrative
Description of Event or Problem
THE PT REC'D TWO SUPRAORBITAL LEADS (FROM THE SAME LOT) AND TWO OCCIPITAL LEADS AS PART OF HER NEUROSTIMULATOR SYSTEM (OFF-LABEL). IT WAS REPORTED THE PT WAS UNHAPPY WITH HER STIMULATION COVERAGE AND AN X-RAY SHOWED POSSIBLE LEAD MIGRATION FOR HER RIGHT SUPRAORBITAL LEAD. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.