Description of Event or Problem · 1
THE END-USER STATES SHE WAS SHOCKED WHILE USING THE TENS UNIT. THE END-USER HAD PLACED THE ELECTRODES ON BOTH OF HER HANDS FOR NEUROPATHY FOR 30 MINUTES. SHE HAD THE DEVICE INCREASED TO ONLY 3 MA. IT WAS 3 MINUTES BEFORE THE END OF THE TREATMENT, WHEN SHE DECIDED TO TURN THE DEVICE TO 0 AMPS. AS SOON AS SHE HIT THE ARROW DOWN, THE DEVICE RAMPED UP IN INTENSITY AND SHOCKED HER. SHE STATED THE DEVICE "PARALYZED HER HAND," AND WAS THE "MOST HORRENDOUS PAIN" SHE HAD EVER FELT. SHE CRIED OUT, AND HER BROTHER-IN-LAW CAME DOWN FROM UPSTAIRS TO SHUT THE DEVICE OFF FOR HER. SHE STATES IT TOOK HIM ABOUT ONE MINUTE TO GET TO HER WHILE SHE WAS REPEATEDLY BEING SHOCKED. THE ELECTRODES HAD BEEN PLACED BETWEEN THE BASE OF HER PINKY AND HER WRIST, WITH THE OTHER ONE AT THE MEATY PART OF HER HAND BETWEEN HER POINTER FINGER AND HER THUMB. THIS PLACEMENT WAS DUPLICATED ON HER OPPOSITE HAND. SHE DID NOT RECEIVE A BURN, AND SHE DID NOT SEE HER DOCTOR. HOWEVER, SHE HAS A FULL NEUROLOGICAL EVALUATION ON (B)(6), AND SEES HER CARDIOLOGIST ON (B)(6). THE ELECTRODES SHE WAS USING WERE USED APPROXIMATELY 25 TIMES PRIOR. SHE STATED SHE BEGAN USING THIS DEVICE ON (B)(6), WHEN SHE VISITED THE THERAPIST WHO PROVIDED INSTRUCTIONS FOR USE ON THE DEVICE - THEY WERE USED ONCE PER DAY UNTIL THE INCIDENT. A (B)(4) BRANDS CUSTOMER SERVICE REPRESENTATIVE EXPLAINED THAT THE ELECTRODES WERE TO HAVE BEEN REPLACED AFTER 8-10 USES. THE RETURNED DEVICE WAS TESTED WITHIN SPEC RANGE- NO DEFECTS WERE FOUND.