FDA Adverse Event Injury Summary report: N

SENZA HFX IMPLANT OMNIA SCS SYSTEM

MDR report key: 17855903 · Received September 29, 2023

Report

Report Number
MW5146358
Event Type
Injury
Date Received
September 29, 2023
Date of Event
February 17, 2023
Report Date
September 27, 2023
Manufacturer
NEVRO CORP.
Product Code
LGW
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NV, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD PLACEMENT OF A SPINAL CORD STIMULATOR (NEVRO SENZA HFX IMPLANT OMNIA SCS SYSTEM) ON (B)(6) 2023. ON (B)(6) 2023 I WAS HOSPITALIZED DUE TO INCREASED UNBEARABLE PAIN. I WAS TOLD IT WAS POST-OP PAIN, GIVEN MULTIPLE PAIN MEDICATIONS WHILE IN THE HOSPITAL. DISCHARGE AND REMAINED ON PAIN MEDICATION FOR APPROXIMATELY TWO WEEKS FOLLOWING DISCHARGE. I DO NOT LIKE TAKING PAIN MEDICATION THAT IS WHY I GOT THE SCS. I HAVE NOT TAKEN PAIN MEDICATION SINCE (B)(6). I THEN FOLLOWED UP WITH PAIN MANAGEMENT, NEVRO REPRESENTATIVE AND SURGEON. I WAS GETTING VERY MINIMAL RELIEF. I KEPT TELLING NEVRO AND PAIN MANAGEMENT THAT I WAS NOT GETTING RELIEF. HAD CONTINUES PAIN, EPISODES OF DIZZINESS, BALANCE ISSUES AND SLEEP ISSUES. THE DOCTORS WERE LOOKING AT ME LIKE I WAS CRAZY, AND NOBODY WAS LISTENING. IN LATE JUNE I KEPT HAVING TO RECHARGE MY STIMULATOR EVERY TWO DAYS, WHEN I SPOKE WITH THE NEVRO REP. THEY SAID THAT SOMETIMES HAPPENS. THIS WENT ON FOR WEEKS. ON JULY 14,2023 I WAS IN BED AND RECEIVE AN ELECTRIC JOLT TO MY LEFT LEG, IT LIFTED MY LEG AND TWISTED MY LEG FROM MY FOOT TO MY HIP INTERNAL ROTATION OF MY ENTIRE LEG. CAUSING ME TO HAVE SEVERE PAIN TO MY ENTIRE LEG AND BACK. I CALLED NEVRO CUSTOMER SERVICE IN THE MORNING AND NO RETURN CALL. I THEN TEXTED THE REP WHO WAS AT MY SURGERY AND SHE RETURNED MY CALL. I FOLLOWED HER INSTRUCTIONS. ON (B)(6) WHILE IN BED, I RECEIVED A SECOND JOLT TO THE BATTERY OF THE STIMULATOR CAUSING A LOT OF PAIN AND SORENESS AT THE SITE. CALLED NEVRO IT TOOK THREE PHONE CALLS BEFORE THEY GOT BACK TO ME ON (B)(6). THEY SAID THAT I WAS SET ON A GROUP THAT GAVE CONTINUOUS STIMULATION AND SOMETIMES THAT HAPPENS. WENT TO PAIN MANAGEMENT MADE THEM AWARE OF THE SITUATION AND THE SEVERE PAIN I WAS IN. THEY HAD THE NEVO REP MEET WITH ME AND SENT ME BACK TO THE SURGEON. AGAIN, LOOKING AT ME LIKE I WAS NUTS. THE NEVRO REP. WANTED X-RAY TO SEE IF SOMETHING MOVED, SURGEON DISAGREED. FINALLY PAIN MANAGEMENT ORDERED X-RAYS. APPARENTLY, THE LABELING ON THE LEAD IMPLANT WERE INCORRECT AND THE LEADS SHIFTED. SO NOW I REMAIN IN PAIN AND NEVRO IS ATTEMPTING TO FIND A PROGRAM TO HELP ME, BECAUSE FOR THE PAST 7 MONTHS THE PROGRAMING WAS INCORRECT FOR THE AREA PLACED. THIS JOLT TO MY LEG HAS CAUSED ME SEVER PAIN AND I HAVE NOT SLEPT IN APPROXIMATELY 7 MONTHS DUE TO PAIN. THIS DEVISE HAS CAUSED ME TO HAVE MULTIPLE PROBLEMS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
589715 SENZA HFX IMPLANT OMNIA SCS SYSTEM STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEVRO CORP. NIPG2500 892795

Patients

Seq Age Sex Outcome Treatment
1 67 YR Female Other| H| R "PAIN MEDICATION" | AMBIEN| ATORVASTATIN | BABY ASPIRIN | VITAMIN D