FDA Adverse Event Summary report: N

MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

MDR report key: 2881680 · Received December 17, 2012

Report

Report Number
MW5028230
Date Received
December 17, 2012
Date of Event
July 9, 2007
Report Date
November 21, 2012
Manufacturer
MEDTRONIC INC
Product Code
NEK
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MO, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

THE MEDTRONIC INFUSE WAS IMPLANTED DURING MY SPINAL SURGERY LEAVING ME TO SUFFER IN PAIN. SINCE THE SURGERY I AM REQUIRED TO VISIT MY DR FREQUENTLY. I'M WORRIED THINGS WILL GET WORSE. HE HAS INFORMED ME THINGS HAVE GOTTEN A LOT WORSE. CARPAL TUNNEL SYNDROME FROM NERVE DAMAGE. NEUROLOGICAL TESTS RAN BEFORE SURGERY AND I AM IN MUCH WORSE CONDITION THAN BEFORE THE SURGERY. THE DOCTOR WHO DID THE SURGERY NEVER GAVE ME ANY REHAB, HARD COLLAR, DIRECTIONS OR HELP AFTER HE BOTCHED THE SURGERY. WHEN I CALLED HIM FOR HELP, HIS NURSE TOLD ME HE LEFT FOR (B)(6) 3-4 WEEKS AFTER MY SURGERY AND NEVER REFERRED ME TO ANOTHER DOCTOR, NOR DID HE TRY TO HELP ME. ANYWAY, AFTER HE MADE MY NECK WORSE NOW THAN IT WAS. I HAVE IN HOME CARE FOR BATHING, COOKING, CLEANING, AND CANNOT EVEN DRIVE ANYMORE. I SUFFER FROM PAIN 24 HOURS A DAY. I HAVE TERRIBLE MEMORY LOSS PROBLEMS, I AM DEPRESSED TO THE POINT THAT I HAVE SEVERE PANIC ATTACKS, FAINTING SPELLS, SWEATS, NIGHTMARES, SHAKES, AND I DO NOT LEAVE MY HOME UNLESS I HAVE TO GO TO THE DOCTOR, PSYCHOLOGIST, OR BLOOD TEST, MRI'S, X-RAYS. THE DOCTOR WHO ORIGINALLY PERFORMED THE INFUSION HAS NOT BEEN HEARD FROM SINCE HE RUINED MY NECK. MY NECK HURTS SO BAD THAT NOW THERE IS SOMETHING WRONG WITH THE LOWER PART OF MY BACK AND AT TIMES I CANNOT FEEL MY LEGS. MY ARTHRITIS HAS GOTTEN SO BAD I PRETTY MUCH SPEND ALL MY NON-MEDICAL TIME IN BED OR A RECLINER. MY LIFE IS OVER SINCE THAT DOCTOR RUINED MY NECK FROM THE BONE GRAFT SURGERY AND REPLACED THE NERVES IN MY NECK WITH ARTIFICIAL ONES. WHEN HE SCREWED THE DEVICE INTO MY NECK THE SCREW BROKE A VERTEBRA ON THE BACK OF MY SPINE AND IT NOW LAYS ON TOP OF THE NEW NERVES CAUSING ME TO FEEL LIKE I HAVE ELECTRICAL SHARDS IN MY NECK AND SPINE. WHENEVER I TURN MY HEAD LEFT TO RIGHT OR UP AND DOWN. I FEEL HORRIBLE PAIN. MY LIFE IS CONSUMED WITH PAIN AND I CANNOT EVEN BE A WIFE TO MY HUSBAND WHO WANTS A DIVORCE BECAUSE I¿M USELESS. IT HURTS TO HAVE SEX AND NOW MY THYROID IS GOING OUT ON ME. MY CHOLESTEROL IS RIGHT AT 700, IT IS ONLY SUPPOSED TO BE 120. IT WOULD SURPRISE ME IF I LIVE ANOTHER YEAR. IT IS MANDATORY FOR ME TO SEE MY FAMILY PRACTITIONER EVERY MONTH, MY PSYCHOLOGIST EVERY 2 WEEKS, AND PSYCHIATRIST EVERY 2 MONTHS. MY CAREGIVER COMES TO MY HOME 3 TO 4 TIMES A WEEK. THE COURTS TOOK AWAY MY DRIVER¿S LICENSE BECAUSE OF THE MEDICATION I HAVE TO TAKE. BECAUSE OF THE PERMANENT DAMAGE FROM THE BONE GRAFT FUSION I¿LL NEVER BE ABLE TO DRIVE AGAIN, BATHE MYSELF SAFELY, WALK NORMALLY OR WITHOUT A WALKER/OR WHEELCHAIR. I WILL NEED A SURGERY AGAIN FROM THE DAMAGE THE DEVICE IS CAUSING IN NECK AND SPINE. I WILL BE ON MEDICATION FOR THE REST OF MY LIFE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC INC UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 46 YR Required Intervention| S