BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1752623 · Received June 29, 2010

    Report

    Report Number
    MW5016646
    Event Type
    Injury
    Date Received
    June 29, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 29, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2010, I WAS IMPLANTED WITH THE MEDTRONICS SPINAL STIMULATOR FOR PAIN MANAGEMENT -AS A LAST RESORT-. AFTER THE SURGERY, I REMAINED IN SEVERE PAIN FOR 10 DAYS UNTIL I SAW MY PHYSICIAN, AND HE SAID THERE WAS INFECTION AND THAT I NEEDED AN EMERGENCY OPERATION IMMEDIATELY TO OPEN MY BACK UP AND CLEAN OUT ALL OF THE INFECTION AND REMOVE THE SOURCE OF THE INFECTION WHICH WAS THE MEDTRONIC SPINAL STIMULATOR, SO NOW 2 INVASIVE BACK SURGERIES IN 10 DAYS TIME. NOW, NOT ONLY DO I HAVE THE ORIGINAL PAIN THAT I HAD BEFORE THE SPINAL STIMULATOR, BUT NOW I AM STILL FIGHTING THE SEVERE INFECTION WITH HIGH DOSES OF ANTIBIOTICS AND A HIGH DOSE OF PAIN MEDICATION, BUT I ALSO NOW HAVE THE PAIN FROM HAVING 2 SURGERIES IN 10 DAYS. I WAS DISABLED BEFORE AND NOW EVEN MORE DISABLED. MEDTRONICS TOOK MY LIFE AWAY AND THE ONLY RESPONSE THAT I RECEIVED FROM THEM WAS "SORRY". DATES OF USE: DAYS, (B) (6)2010 - (B) (6)2010. DIAGNOSIS OR REASON FOR USE: SEVERE LUMBAR BACK PAIN WITH NO OTHER REMEDIES FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MEDTRONIC NEURO SPINAL STIMULATOR LGW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention| S