MAUDE Adverse Event Report: NEVRO CORP. NEVRO HF-10 SPINAL CORD STIMULATOR SENZA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NOG1500/ LEAD 1058-50B/ LEAD1058

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Migration (4003)

Patient Problems Fall (1848); Failure of Implant (1924); Burning Sensation (2146); Inadequate Pain Relief (2388); Ambulation Difficulties (2544); Shock from Patient Lead(s) (3162); Peripheral Nervous Injury (4414); Vertebral Fracture (4520)

Event Date 09/25/2018

Event Type  Injury  

Event Description

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 vertebrae in half.Had to have surgery and surgeon put cement in my back.It continued, the company neuro 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 since 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 cheek.Please help if you can.None of the people involved have tried to help me.I have been ignored, snowballed, this or that they can't talk to me.They are crooks, that have no compassion for human life.It has taken me 4 years for a doctor to finally tell me the truth.I tried to tell nevro, the doctor that put it in, but no one will talk.They have committed fraud so many time it's not be funny.I need help i am dragging my left leg when i can get up.When i try to charge i can only do a few minutes at a time because it starts burning me from the inside out.Can you help me they will not talk to me.The rep said what she done when she adjusted my unit was illegal.If you can help i would appreciate it very much.Fda safety report id# (b)(4).

• Brand Name: NEVRO HF-10 SPINAL CORD STIMULATOR SENZA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO CORP.
• MDR Report Key: 15130261
• MDR Text Key: 297003674
• Report Number: MW5111180
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2018
• Device Model Number: NOG1500/ LEAD 1058-50B/ LEAD1058
• Device Catalogue Number: CHGR1000
• Device Lot Number: 9442844
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: B12; DEER ANTLER VELVET ; INTRATHECAL PAIN PUMP BEING INSTALLED ; KETAMINE; MILK THISTLE; NORCO; PROBIOTICS ; PROTEIN; SOMA; TRAZADONE; VIT D; VITAMIN C; ZINC
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White