FDA Adverse Event Injury Summary report: N

MEDTRONIC

MDR report key: 2398433 · Received January 2, 2012

Report

Report Number
MW5023676
Event Type
Injury
Date Received
January 2, 2012
Date of Event
August 3, 2010
Manufacturer
MEDTRONIC
Product Code
KWQ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

TWO FAILED BACK SURGERIES: DATES: (B)(6) 2010, LUMBAR LAMINECTOMIES, (B)(6) 2010, THREE-LEVEL-LUMBAR FUSION (ALIF). EQUIPMENT USED: MEDTRONIC (ACCORDING TO OPERATIVE REPORT). DATE I BECAME AWARE OF THIS EVENT: FROM (B)(6) 2011. DR. (B)(6) ORDERED THE MRI OF MY HIPS RELATED TO MY SEVERE PAIN. WHEN HE REC'D THE RESULTS, HE HAD HIS NURSE, (B)(6), CALL ME AND SHE SAID I HAD HIP BURSITIS AND TO SEE MY RHEUMATOLOGIST, DR. (B)(6), WHICH I DID. IT WAS AT DR. (B)(6) OFFICE VISIT THAT I GOT A COPY OF THE MRI. I ASKED DR. (B)(6) ABOUT THE "DENERVATION" PART OF THE MRI FINDINGS AND HE TOLD ME TO SEE MY NEUROLOGIST, DR. (B)(6). THIS I DID AND HE DID ANOTHER MRI AND ANOTHER SPECIAL EMG. AT THE "RESULTS" APPOINTMENT, DR. (B)(6) TOLD MY HUSBAND AND ME "THE DAMAGE MOST LIKELY OCCURRED A THE SECOND SURGERY ((B)(6) 2010)." DR. (B)(6) STATED HE COULD NOT PUT THAT IN HIS REPORT. WE TOOK IT HIS JOB WAS AT STAKE FOR HE DISMISSED US TO THE HEAD OF NEUROLOGY, DR. (B)(6), WHO I SAW AND WHO WANTS TO DO MANY MORE COSTLY TESTS ON ME. I CANNOT DO THEM AS I HAVE NO INSURANCE AND TRULY BELIEVE IT IS (B)(4) WAY OF GIVING US THE RUN-AROUND. PRIOR TO THE SECOND SURGERY, I WAS NEVER PUT ON ANY SHORT- OR LONG-TERM PHYSICAL THERAPY OR PAIN PROGRAMS. YET, THIS HUGE THREE-LEVEL-LUMBAR FUSION WAS APPROVED BY (B)(4), WHO WAS ALSO MY MEDICAL INSURANCE CARRIER AT THE TIME. MOST INSURANCE COMPANIES REQUIRE LONG-TERM PHYSICAL THERAPY AND PAIN MANAGEMENT PROGRAMS BEFORE AUTHORIZING EVEN ONE- AND/OR TWO-LEVEL FUSIONS. MANY DO NOT APPROVE ANY FUSIONS AT ALL. I HAVE SINCE FOUND OUT THROUGH SOME VERY INFLUENTIAL RPTRS THAT SURGEONS ARE GIVE "KICKBACKS" AND "ROYALTIES" FOR THE HARDWARE THEY USE ON PTS FOR SPINAL FUSIONS. THEY HAVE ALSO INFORMED ME THAT THREE-LEVEL-LUMBAR FUSIONS ARE RARELY DONE BECAUSE THE OUTCOMES ARE ALWAYS POOR. ANOTHER THING, I WAS GIVEN A BOOK, THE BETTER WAY BACK PRIOR TO MY SECOND SURGERY. THE BOOK PROMOTES XLIF SURGERY. I WAS TOLD THAT SOME EXTREME FIGHTER WITH A NAME LIKE "(B)(6)" HAD RECENTLY BEEN IN DR. (B)(6) OFFICE PUSHING THE BOOK. SOMETHING SMELLS LIKE FISH. I WAS A REGISTERED NURSE AT (B)(4) CLINIC, AND I CHERISHED MY JOB. NOW I AM ON SOCIAL SECURITY AND CAN ONLY WALK A MERE FIVE YARDS W/O SITTING DOWN. I KNOW WHAT PAIN IS, YES. HOWEVER, TO SEE SIX OF OUR HOUSES GO INTO FORECLOSURE-OUR DAUGHTER'S FUTURE INHERITANCE-CAUSES A CERTAIN UNRELENTING SUFFERING NO PILL CAN DEADEN. THAT SUFFERING IS CALLED INJUSTICE. OUR DAUGHTER WAS ADOPTED THROUGH THE COUNTY OF (B)(6). SHE WAS A VERY SICK PREEMIE BORN AT HOME TO A TEENAGE MOM. SHE HAD MANY SPECIAL NEEDS AND NOW AT (B)(6), SUFFERS FROM SEVERE ATTENTION DEFICIT. SHE NEEDS CONSTANT HELP AND REMINDERS AND IS ON ADDERALL. TO MAKE MATTERS WORSE, THIS ADVERSE EVENT HAS CAUSED MARITAL INSTABILITY. THIS IS MY WAY OF REPORTING AN ADVERSE EVENT, WHICH THE SURGEON, DR. (B)(6), SHOULD HAVE REPORTED WITHIN HIS ALLOTTED FRAME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC THREE-LEVEL-LUMBAR FUSION (ALIF) KWQ MEDTRONIC

Patients

Seq Age Sex Outcome Treatment
1 52 YR