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

Lot Number 9449182

Device Problem Migration (4003)

Patient Problems Anaphylactic Shock (1703); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Headache (1880); Failure of Implant (1924); Pain (1994); Tinnitus (2103); Numbness (2415); Cognitive Changes (2551); Angioedema (4536)

Event Date 03/22/2021

Event Type  Injury  

Event Description

Hello, my name is (b)(6), i am the director of flight operations in (b)(6) for a company that operates five worldwide (b)(6) airlines.I was injured in (b)(6) in (b)(6) 2019 and returned back to the usa for treatment.After two successful fusions in my toes my next surgery was a trial spinal cord stimulator that was successful.My permanent spinal cord implant was not the same as my trial.I was only told of positive stories from my nevro representatives and my doctor.I did not know that i was going to have the surgery at a surgery center that my doctor had ownership in.I woke up from surgery on (b)(6) 2021 with an elephant on my chest, couldn't swallow and was experiencing level 9 pain.I was released because it was two hours past the closing time of the surgery center.Four (4) hours later awoken from my personal bed at home coughing up copious amounts of blood with clots and a rash on my chest, my family rushed me to the closest emergency room an i was treated for anaphylactic shock.I continued to cough up blood for 9 days and have a numb tongue, numb lower lip, side of face twitching eye lid area and could not swallow.My back was great if not awesome.Because i was afraid to choke during my swallowing efforts, and biting my lower lip i went to the er to get it looked at.The er doctor wanted a ct scan so we turned off my spinal cord stimulator and i was shocked over and over again for 10 mins until we could get in touch with a nevro rep that advised me to turn the device back on.Shocking stopped.For the weeks to follow every time i turned on or off the stimulator i received shocks.The worst two times caused lightning bolts up my spine into the base of my neck causing my vision to go dark.At that same time i felt an elephant on my chest, the same experience that i originally had in the recovery room after my surgery on (b)(6) 2021.My heart was racing so fast and loud.I had lightning bolts coming out my small fingers of both hands.My memory has not been the same.I experienced a severe migraine causing me to throw up.I visited the er four times from the time i had the spinal cord stimulator permanently implanted.My swallowing issues intensified to the same level as when i was in the recovery room.I permanently turned off my stimulator on day 42 after being shocked and suffering bowel and bladder incontinence with severe migraines and tinnitus, along with the numb issues of the mouth.On day 43 when talking to my nevro reprehensive and doctor about these issues they said all is good on the nevro side and that it was me being sensitive.They stated they never heard of anything like this.The day before my in person visit with them i did some research and printed the fda maude and hundreds of cases of patients that have had problems similar or identical to mine.When i addressed this with the rep she became highly agitated and slammed her computer shut and stormed out of the office.My doctor suddenly changed his direction of the conversation and stated that none of the cases were adjudicated.My doctor then had me get an x-ray where he saw that the leads had migrated.I believe the doctor broke his oath in not advising me that there were so many known issues with this nevro senza omnia stimulator.Day 49 (b)(6) 2021.I urgently had the spinal cord stimulator removed.Unfortunately i still suffer with incontinence, headache, tinnitus and facial numbness along with shooting pain down both legs and feet.My brain still feels stunned and my memory is foggy.This is very scary as my devise was shut off on day 42 and is now removed from my body.Day 58 (b)(6) 2021 i still suffer with incontinence, headache, tinnitus and facial numbness along with shooting pain down both legs and feet.My brain still feels stunned and my memory is foggy.The world needs to know my story, so that future patients will not fall into this trap.All my best, (b)(6).X ray showed lead migration.Fda safety report id # (b)(4).

• Brand Name: SENZA SPINAL CORD STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO CORP.
• MDR Report Key: 11869969
• MDR Text Key: 252906316
• Report Number: MW5101497
• Device Sequence Number: 1
• Product Code: LGW
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 9449182
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 113