EON MINI
Received Oct 27, 2014 · Event occurred Oct 3, 2014
Report 1627487-2014-26884 · MDR key 4235958
Device
Product problems
- Extracardiac stimulation
Patient
48 YR
- Discomfort
Narrative
Description of Event or Problem
IT WAS REPORTED THE PATIENT IS EXPERIENCING A JOLTING SENSATION FOR 3-4 MINUTES AT THE IPG SITE WHEN STIMULATION IS INITIALLY TURNED ON WHICH EVENTUALLY SUBSIDES. THE PATIENT WILL BE FOLLOWING UP WITH HIS PHYSICIAN IN THE FUTURE.
Additional Manufacturer Narrative
CORRECTION NUMBERS: 1627487-07262012-002-R, 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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
- Recall