FDA Adverse Event Injury Summary report: N

HFX

MDR report key: 23447323 · Received November 3, 2025

Report

Report Number
MW5178448
Event Type
Injury
Date Received
November 3, 2025
Date of Event
October 27, 2025
Report Date
October 29, 2025
Manufacturer
NEVRO CORP.
Product Code
LGW
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD A NEVROHFX NEUROSTIMULATOR INSERTED IN MY BACK DUE TO BACK PAIN ON (B)(6) 2025. SINCE THE IMPLANT, I HAVE NOTICED WEAKNESS IN MY RIGHT LEG AND SOMETHING SIMILAR TO A FOOT DROP. I MENTIONED THIS TO THE NEVRO REP WITHIN THE FIRST COUPLE DAYS OF THE SURGERY AND WAS TOLD THAT THIS WAS AN EXPECTED OUTCOME OF THE SURGERY AND THAT IT WOULD IMPROVE. I HAVE CONTINUED TO MENTION THIS CONCERN ON MULTIPLE CALLS TO THE REP AND DURING MY FOLLOW UP APPOINTMENTS. NO ONE SEEMED TO SEE IT AS AN ISSUE, BUT ME AS "THE PATIENT" AND AS A REGISTERED NURSE, I HAVE BEEN CONCERNED ABOUT THIS. I HAVE NOT RECEIVED COMPLETE CONTROL OF MY PAIN, WHICH I UNDERSTAND WILL TAKE TIME. THE CONCERNS THAT HAVE HAPPENED SINCE I HAD THE NEUROSTIMULATOR PLACED IS THAT I HAD TWO FALLS WITH INJURIES. THE FIRST FALL OCCURRED ABOUT SIX WEEKS AGO. I WAS GETTING OUT OF CAR AND MY RIGHT LEG GAVE OUT AND I FELL. I TRIED TO PROTECT MY HEAD AND BACK FROM HITTING THE CEMENT CORNER OF PORCH. I LANDED ON MY RIGHT SHOULDER, BUT MY LEG HIT A METAL SCULPTURE RESULTING IN AN APPROXIMATELY 2 INCH BY 1 INCH TEAR IN MY LEG. I DID CHOOSE TO NOT GET STITCHES, EVEN THOUGH I SHOULD HAVE. I HAVE BEEN DOING WOUND CARE TO MY LEG. ON (B)(6) 2025, I HAD JUST GOTTEN DONE WALKING OUR DOGS. I WALK THE DOGS MOST EVERY MORNING. I CAN TOLERATE ABOUT A 1/2 MILE TO .6 MILE AT MOST (LESS THAN WHAT I WAS DOING PRIOR TO INSERTION AND I WALK SLOWER AS I DON'T TRUST MY LEGS, BUT MAINLY MY RIGHT LEG). I SOMEHOW LOST MY BALANCE AND COULD NOT REGAIN CONTROL OF MY LEGS (IT WAS NOT DUE TO MY DOGS) AND I FELL BACKWARDS. I ENDED UP HITTING MY HEAD ON THE PAVEMENT AND WAS KNOCKED ON UNCONSCIOUS. I THOUGHT THAT IT WAS FOR ABOUT 30 SECONDS, BUT IT APPEARS IT MAY HAVE BEEN CLOSER TO 45 SECONDS. I WENT TO THE EMERGENCY ROOM AND A CT WAS DONE. IT WAS NEGATIVE FOR A BLEED. I DID HAVE 10 STAPLES PLACED AND MULTIPLE STITCHES TO THE POSTERIOR ASPECT OF MY HEAD. THE ED PROVIDER ALSO REFERRED ME TO WOUND CARE, AS HE IS NOT SURE IF ONE AREA OF THE SCALP WILL SURVIVE. I NOTIFIED BOTH NEVRO AND THE PAIN DOCTOR REGARDING THIS INCIDENT. NEVRO, IN MY OPINION DID NOT SEEM OVERLY CONCERNED ABOUT EITHER FALL OR WHAT I HAVE BEEN SAYING ABOUT THE RIGHT LEG. I HAVE NOT HEARD FROM THE PAIN DOCTOR. I HAVE EVEN ASKED TO HAVE THIS REMOVED (THE EFFECTIVENESS, UNCOMFORTABLE IN THE AREA OF THE BATTERY PACK, INTERMITTENT TIMES OF FEELING SHOCKS, AND DUE TO THE INJURIES) AND WAS TOLD TO GIVE THIS TIME, AS I NEED TO GIVE IT MORE TIME. I ALSO TRIED TO CALL THE CORPORATE NUMBER WHICH WILL ONLY LOOP YOU THROUGH OPTIONS, BUT YOU CANNOT REACH A PERSON OR LEAVE A MESSAGE. I DID FILL OUT A FORM REGARDING MY CONCERNS; THIS WAS PRIOR TO THIS MOST RECENT FALL (DONE (B)(6) 2025). IT IS CONCERNING THAT I HAVE TO HAD TWO FALLS WITH INJURIES SINCE I HAVE THE NEUROSTIMULATOR PLACED AND PRIOR TO THE PLACEMENT, I HAD NOT HAD FALLS AND CERTAINLY NOT FALLS WITH INJURIES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
224897 HFX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEVRO CORP.

Patients

Seq Age Sex Outcome Treatment
1 58 YR Female Other AIMOVIG 70 MG INJECTOR QMO.| B12 1000 MCG QD.| CALCIUM 600 MG 2 TABS QD.| IRON 65 MG QOD.| MAGNESIUM 250 QD.| PRONTONIX 40 MG QD.| QVAR, 80 MG 2 PUFFS QD.| SUPER B COMPLEX 500 MG QD.| TOPAMAX 100 MG 2 TABS BID.| TRAMADOL 50 MG 2 TABS QD.