Description of Event or Problem · 1
I HAD A NEVRO SPINAL CORD STIMULATOR IMPLANTED ON (B)(6) 2017. WITHIN SIX MONTHS, THE PADDLE ELECTRODES STARTED TO FAIL. FROM (B)(6) 2017 TO (B)(6) 2018 THEY TRIED TO WORK AROUND THE FAILING ELECTRODES, WHICH, AS OF (B)(6) 2018, SIX OF THE 18 HAD FAILED AND COULD NO LONGER BE USED. I WAS SUPPOSED TO HEAR BACK FROM NEVRO WITHIN TWO WEEKS OF THAT DATE. BUT NEVER HEARD BACK FROM THEM AGAIN UNTIL TWO WEEKS AGO AFTER I CALLED AND COMPLAINED TO MY DRS THAT NEVRO WOULD NOT AND HAD NOT GOT IN TOUCH TO FIX THEIR EQUIPMENT. I FINALLY TALKED TO A MGR YESTERDAY. HE WOULD NOT ANSWER ANY QUESTION ON WHY NEVRO STOPPED TRYING TO FIX THEIR MALFUNCTIONING PIECE OF EQUIPMENT. HE WOULD NOT ANSWER WHY IT HAS BEEN ALMOST 11 MONTHS SINCE I HAVE HEARD FROM ANYONE OF THEM. HE DID NOT OFFER TO FIX IT. HIS ONLY CONCERN WAS THEY GET IT BACK TO RUN TEST ON IT. HE SAID THOSE RESULTS WOULD GO TO THE FDA, BUT I DO NOT BELIEVE THAT FOR ONE SECOND. I ALSO ASKED WHY NEVRO USES BIASED SURVEYS TO COME UP WITH THEIR PERCENTAGE RATES OF SUCCESS WITH PTS. THOSE SURVEYS DO NOT ALLOW ANY NEGATIVE FEEDBACK, BUT ARE USED TO CALCULATE POSITIVE RESULTS. I HAVE NO FAITH THAT NEVRO WOULD DO ANYTHING BUT MAKE THIS GO AWAY AS QUICKLY AS POSSIBLE AND NOT GIVE THE FDA THE PROPER DOCUMENTATION OF ITS UNIT'S FAILURE. THAT'S WHY I HAVE REQUESTED THAT I RETAIN ALL COMPONENTS WHEN I GET THIS REMOVED IN (B)(6). I WOULD LIKE THE FDA TO GET IT SO YOU CAN SEE FOR YOURSELVES THAT THE PRODUCT WAS FAILING AND NEVRO DID NOT HONOR THE WARRANTY ON THE UNIT. THE PADDLE HAS 16 ELECTRODES ON THE LEAD, MY NEUROSURGEON SAYS IF ONE FAILS, IT'S OK BUT IF 2 OR MORE IT'S PROBLEM WITH THE LEAD, AND IT SHOULD HAVE BEEN REPLACED. MY SURGEON WAS NEVER GIVEN THE INFO ON THE FAILING LEADS OTHER THAN WHAT I GAVE HER. NEVRO NEVER INFORMED HER OF THE FAILURE OTHER THAN THEY WERE WORKING ON RE-PROGRAMMING AROUND THEM. THAT WAS UNTIL THEY GAVE UP ALTOGETHER LAST (B)(6) 2018. FDA SAFETY REPORT ID# (B)(4).