BRIO
Received Nov 21, 2014 · Event occurred Oct 27, 2014
Report 1627487-2014-25680 · MDR key 4283569
Device
Product problems
- Communication or Transmission Problem
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THE PT'S (B)(6) IPG IS NOT COMMUNICATING WITH THE CLINICIAN OR PT PROGRAMMER AND CHARGER. ADDITIONALLY, IT IS UNK IF THE IPG AND CHARGER. ADDITIONALLY, IT IS UNK IF THE IPG COULD COMMUNICATE WITH THE PROGRAMMERS OR CHARGER PRIOR TO IMPLANT. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT AND REPLACE THE IPG.
Additional Manufacturer Narrative
THIS DEVICE IS NOT APPROVED FOR SALE IN THE US. SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.