EON MINI

Description of Event or Problem

DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-06258. INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY, INDICATED THE PATIENT ALLEGES SHE EXPERIENCED OVERHEATING AND BURNING AT THE IMPLANT SITE. PER A LEGAL PRESERVATION NOTICE, THIS PATIENT WAS EXPLANTED (B)(6) 2014. ADDITIONAL INFORMATION IS NEEDED TO CLARIFY THE NATURE OF THE PATIENT'S ISSUES. SJM WAS MADE AWARE OF THE ISSUES ON (B)(6) 2014, AND THE PATIENT'S SCS SYSTEM WAS NOT EVALUATED BY AN SJM REPRESENTATIVE TO VERIFY AND/OR TROUBLESHOOT ANY OF THE REPORTED ISSUES PRIOR TO EXPLANT. ON (B)(6) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

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.

Description of Event or Problem

DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-06258. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE PATIENT'S SCS SYSTEM WAS REMOVED ON (B)(6)2014. REVIEW OF THE PATIENT'S MEDICAL RECORD IDENTIFIED THE PATIENT UNDERWENT EXPLANT TO OBTAIN MRI TO FURTHER DIAGNOSE PATIENTS CHRONIC LOW BACK PAIN AND CONSIDER OTHER TREATMENT OPTIONS.

Additional Manufacturer Narrative

(B)(4). THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND A FIELD CORRECTION. 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.