FDA Adverse Event Injury Summary report: N

SENCO NEVRO HF-10 "SCS"

MDR report key: 15043760 · Received July 15, 2022

Report

Report Number
MW5110923
Event Type
Injury
Date Received
July 15, 2022
Date of Event
May 25, 2018
Report Date
July 14, 2022
Manufacturer
NEVRO CORP.
Product Code
LGW
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OK, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD A SPINAL CORD STIMULATOR. INSTALLED IN 2018. IT STARTED SHOCKING AND BURNING ME. IT SHOCKS ME SO HARD IT KNOCKS MY LEGS OUT FROM UNDER ME. IT KNOCKED ME DOWN WHEN I WAS TRYING TO GET OFF TOILET AND I FELL BACKWARDS AND LANDED ON THE TOILET BREAKING MY L-4 VERTEBRA IN HALF. HAD TO HAVE SURGERY AND SURGEON PUT CEMENT IN MY BACK. IT CONTINUED, THE COMPANY NEVERO WOULD NOT ASSERT THE FACT THAT I COULD FEEL IT SHOCKING ME. I KEPT HAVING PROBLEMS SO ONE OF THEIR REPS, TOOK IT OFF HIGH FREQUENCY AND PUT IT ON LOW FREQUENCY AND NOW IT IS STILL SHOCKING ME. WHEN I TRY TO CHARGE THE BATTERY IT STARTS BURNING ME FROM THE INSIDE OUT. I HAVE TO CHARGE UNTIL I CAN'T STAND THE BURNING AND WAIT A BIT AND CHARGE SOME MORE. WHEN I CONTACT THE COMPANY THE REP CALLED ME AND TOLD ME THAT SHE WAS NOT SUPPOSED TO TAKE IT OFF HIGH AND PUT IT ON LOW. SHE ASK ME NOT TO SAY ANYTHING BECAUSE SHE WOULD LOOSE HER JOB AND SO WOULD HER OTHER REP BECAUSE THEY BOTH DONE IT. THEY HAVE IT TURN UP TO MAXIMUM STRETCH FOR A HUMAN BEING. NOW I AM HURTING EVEN WORSE, AND MY LEFT LEG AND FOOT IS GOING PARALYZED AND SOMETIMES IT TAKES 30 MINUTES OR SO MOVING IT AROUND BY HAND TO GET MY LEG OR FOOT TO WORK AGAIN. THE COMPANY HAS KNOWN OF THIS EVER SENSE IT WAS INSTALLED. THE ONLY THING THEY EVER SAID WAS "SORRY YOU BROKE YOUR BACK" I HAVE THAT MESSAGE ON A TEXT MESSAGE. I DON'T KNOW WHAT TO DO, BUT I JUST FOUND OUT RECENTLY THAT I WAS RIGHT AND ONE OF MY LEADS THAT WAS AT T-6, T-7 AND T-8 HAS FELL ALWAYS THE WAY DOWN AND IS WRAPPED AROUND MY BATTERY IN MY LEFT BUTT CHECK. PLEASE HELP IF YOU CAN. I SAW A DOCTOR IN (B)(6) AND TOLD HIM THE STORY AND HE TOOK ME IN THE X-RAY ROOM AND FOUND THE LEAD WRAPPED AROUND MY BATTERY. I CALLED SURGEON BUT THEY WON'T TALK TO ME, ALSO CALLED SENCO NEVRO AND THEY WON'T TALK EITHER. I AM NOT SURE WHAT TO DO AND I NEED HELP. I HAVE THE SENCO NEVRO HF-10 IMPLANTED. THEY HAVE ALL TURNED THEIR BACKS ON ME, THE SURGEON DR. (B)(6), AND NEVRO. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
333545 SENCO NEVRO HF-10 "SCS" STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEVRO CORP. NIPG1500 9442844

Patients

Seq Age Sex Outcome Treatment
1 59 YR Male Hospitalization ADDERALL | ASHWAGANDHA| DEER ANTLER VELVET AND EMERGENC| KETAMINE| LIBERUM | MILK THISTLE| MOTRIN | NORCO| SINCE| TRANSADONE| TURMERIC / CUMMIN | VIT B12| VITAMIN D