EON MINI
Received May 16, 2014 · Event occurred Mar 28, 2013
Report 1627487-2014-01324 · MDR key 3848317
Device
Product problems
- Temperature Problem
Patient
58 YR
- Burning Sensation
Narrative
Description of Event or Problem
IT WAS REPORTED THE PATIENT EXPERIENCED POCKET HEATING WHILE RECHARGING. A REPLACEMENT CHARGER WAS SENT. THE REPLACEMENT CHARGER RESOLVED THE ISSUE. ON 08/01/2012 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. REFERENCE MFR REPORT #1627487-2014-01325.
Additional Manufacturer Narrative
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.
Remedial action
- Other