MEDTRONIC DEEP BRAIN STIMULATOR
Received Oct 30, 2015 · Event occurred Sep 10, 2015
Report 5196903 · MDR key 5196903
Device
Product problems
- Inappropriate/Inadequate Shock/Stimulation
Patient
27 YR
- Pain
- Skin Discoloration
- Burning Sensation
- Electric Shock
Narrative
Description of Event or Problem
INTERMITTENT SHOCKING. RIGHT FACIAL FLUSHING - BOTH REPORTEDLY STARTED ON (B)(6) 2015, PER MOM. MOM NOTIFIED NEUROSCIENCE CLINIC ON (B)(6) 2015 OF THE ABOVE SYMPTOMS TO DBS. SEEN IN CLINIC ON (B)(6) 2015, WITH X-RAYS. COMPLAINT OF RIGHT NECK ELECTRICAL SHOCKS AND PAIN ABOUT EVERY 30 MINUTES. NO ERYTHEMA OR TENDERNESS AROUND DBS. FOLLOW-UP CLINIC VISIT, AFTER MRI, ON (B)(6) 2015 WITH CONTINUING ELECTRICAL SHOCKS EVERY 30 MINUTES. NOW COMPLAINING OF REDNESS AND INCREASING HEAT WHEN RECHARGING. REVISION SURGERY CURRENTLY SCHEDULED FOR (B)(6) 2015. UNFORTUNATELY, THIS IS THE SECOND INCIDENT OF THIS ISSUE FOR (B)(6). ON (B)(6) 2013 MOM NOTIFIED NEUROSCIENCE CLINIC OF STRINGING BEHIND RIGHT EAR. SHE WAS SEEN IN CLINIC ON (B)(6) 2013 FOR COMPLAINTS OF SHOCKING SENSATION ABOVE THE GENERATOR AND BEHIND THE RIGHT EAR. DEVICE TURNED OFF THAT DAY OR ON (B)(6) 2013 FOR PLACEMENT OF EXTENSIONS BILATERALLY. NEW EXTENSIONS MEDTRONIC 87086 40 CM, RIGHT (B)(4) AND LEFT (B)(4).