BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 12780344 · Received November 8, 2021

    Report

    Report Number
    MW5105199
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    July 20, 2019
    Report Date
    November 4, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    OH MY. I DIDN'T SEE THIS BOX. I PUT MY COMMENTS IN THE ADDITIONAL COMMENTS SECTION. HAD SPINAL CORD STIMULATOR REMOVED AFTER 5 WEEKS. I WOKE UP FROM SURGERY IN HORRENDOUS PAIN. EVEN NOW MY PAIN IS HORRIBLE WHERE THE PADDLE WAS AND IT COMES ALL AROUND TO MY RIBS. I CAN NO LONGER FUNCTION. THE SCAR TISSUE WHERE THE BATTERY WAS HITS A NERVE WHEN I MOVE. I HAD TO BEG THE DR TO TAKE IT OUT. I KNEW SOMETHING WAS WRONG AS SOON AS I WOKE UP IN SO MUCH PAIN. THIS IS SUPPOSED TO BE YOUR LAST RESORT FOR PAIN MANAGEMENT. INSTEAD I'M IN 100 XS MORE PAIN. I WISH THAT THE FDA WOULD GO BACK AND LOOK AT ALL THE PEOPLE THAT THESE DEVICES HAVE PERMANENTLY DISABLED AND THE ONES IT DIDN'T HELP. YES THERE ARE THOSE IT DID HELP. WE TRUST YOU TO PROTECT US AND IT'S NOT GETTING DONE. PLEASE INVESTIGATE THESE DEVICES AND HOW THEY ARE HURTING PEOPLE. SOME HAVE EVEN BEEN PARALYZED. MINE WAS A MEDTRONIC. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665220 MEDTRONIC STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Disability