inforMED
InjuryNHY

MEDTRONIC DEEP BRAIN STIMULATOR

Received Oct 30, 2015 · Event occurred Sep 10, 2015

Report 5196903 · MDR key 5196903

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Product code (NHY)
Manufacturer (Medtronic Navigation, Inc.)
Model (ACTIVA RC 37612)

Device

Generic name

Deep Brain Stimulator (dbs)

Manufacturer

Medtronic

Model number

ACTIVA RC 37612

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).