MalfunctionGZN
EON MINI
Received Aug 13, 2013 · Event occurred Jul 19, 2013
Report 1627487-2013-17143 · MDR key 3366724
Device
Product problems
- Communication or Transmission Problem
Patient
30 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED DURING THE PATIENT'S PERMANENT PROCEDURE, BEFORE THE SCS IPG WAS IMPLANTED, MULTIPLE PATIENT PROGRAMMERS COULD NOT COMMUNICATE WITH THE SCS IPG. SUBSEQUENTLY, A DIFFERENT SCS IPG WAS USED WHICH RESOLVED THE COMMUNICATION ISSUE.
Additional Manufacturer Narrative
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.