FDA Adverse Event Malfunction Summary report: N

ALGOVITA NUVECTRA SPINAL CORD STIMULATOR(SCS)

MDR report key: 12624486 · Received October 12, 2021

Report

Report Number
MW5104562
Event Type
Malfunction
Date Received
October 12, 2021
Date of Event
May 2, 2021
Report Date
October 7, 2021
Manufacturer
NUVECTRA/MINNETRONIX, INC.
Product Code
LGW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ANOTHER SCS WILL BE INSERTED; I HAVE A SPINAL CORD STIMULATOR (SCS) (NUVECTRA ALGOVITA) DEVICE WHICH WAS A SURGICAL PROCEDURE ON (B)(6) 2019. NUVECTRA MODEL #2412. IT WAS FDA APPROVED. I RECEIVED A LETTER IN THE MAIL THAT STATES NUVECTRA WILL BE FILING FOR BANKRUPTCY ON 6/2/2020. WHICH WAS NOT EVEN A YEAR SINCE I HAVE HAD IT PERMANENTLY IN MY BODY. I HAVE NOT RECEIVED ANY CORRESPONDENCE SINCE AND NOW MY SCS IS FAILING. I RECENTLY WENT TO MY SURGEON WHO INSTALLED IT DR. (B)(6), WHO STATED THE ONLY OPTION I HAVE IS TO HAVE A NEW BATTERY INSTALLED. DR. (B)(6) STATED HE HAS DONE THIS WITH MOST OF HIS NUVECTRA PATIENTS. I AM NOW SCHEDULED FOR SURGERY TO RECEIVE A NEW ONE FROM ABBOTT ON (B)(6) 2021. I GUESS THE REASON WHY I AM WRITING IS - I DON'T BELIEVE THIS SHOULD HAVE HAPPENED TO THE PATIENTS. NUVECTRA STATED THEY WILL CONTINUE TO SUPPORT THEIR PATIENTS. I HAVE CALLED THEIR CUSTOMER SUPPORT NUMBER, EMAILED AND HAVE FOUND OUT THE NUMBER IS NOT IN SERVICE SO I'M ASSUMING THE EMAIL IS IN THE SAME STATUS. NOW I AM OFF TO SURGERY AGAIN SINCE MY DEVICE IS NOT FUNCTIONING PROPERLY. WHAT IS A CONSUMER/PATIENT TO DO? I FOR ONE DO NOT BELIEVE THIS COST SHOULD BE ON THE PATIENT NOR THE INSURANCE COMPANY SINCE THEY WERE ALREADY COMPENSATED WHEN IT WAS INSTALLED. THIS WILL BE TIME AND PATIENCE AGAIN FOR ME TO UNDERGO ANOTHER SURGERY BECAUSE NUVECTRA COULDN'T DO WHAT THEY STATED THEY WOULD CONTINUE TO DO. I AM AT A LOSS ON WHY THIS SHOULD BE COMING OUT OF MY POCKET, WHY THIS COMPANY DIDN'T PUT THEIR CUSTOMERS FIRST AND WHY AM I GOING THROUGH THIS AGAIN BECAUSE OF THIS CORPORATION! CAN YOU PLEASE LET ME KNOW WHAT MY NEXT STEPS SHOULD BE? I AM GETTING A NEW DEVICE BECAUSE NUVECTRA DEVICE IS FAILING. I THOUGHT I MIGHT HAVE ANOTHER OPTION BUT I DO NOT. LOOKING FORWARD TO YOUR RESPONSE AND THANK YOU FOR YOUR TIME. (B)(6). FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1516387 ALGOVITA NUVECTRA SPINAL CORD STIMULATOR(SCS) STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NUVECTRA/MINNETRONIX, INC. 2412

Patients

Seq Age Sex Outcome Treatment
1 64 YR Other