BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3827941 · Received May 22, 2014

    Report

    Report Number
    3004209178-2014-09506
    Event Type
    Injury
    Date Received
    May 22, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED ¿I¿VE HAD TROUBLE WITH MY MDT FOR ABOUT 5 MONTHS. AND I¿VE GONE TO PAIN MANAGEMENT AND I¿VE TOLD THEM. I THOUGHT I HAD ARTHRITIS IN IT BUT THEY SAID THERE¿S NO WAY I CAN GET ARTHRITIS BECAUSE IT¿S JUST FLESH AND THAT BONE. BUT AS SOON AS I PUT IT ON IN ABOUT HALF HOUR LATER IT STARTS SHOOTING PAINS ALL AROUND IT AND I HAVE TO TURN IT OFF¿. IT WAS ALSO STATED ¿IT¿S BEEN RUNNING PROPERLY. I HAVE GONE 3-4 TIMES, I FORGOT TO COUNT, AND THEY HAD TO ADJUST IT, THEY¿VE CHECKED IT, AND IT HAD NO LEAKS. BUT AS SOON AS I PUT IT ON I START GETTING THOSE SHOOTING PAINS. I HAVEN¿T PUT IN ON FOR ABOUT A MONTH NOW. CAUSE IT CAUSES BE PAIN SO I TOLD THEM I WANT IT OUT, I WANT IT TAKEN OUT¿. THERE WAS NO DATE FOR THE REMOVAL YET, ¿AS LONG AS I DON¿T HAVE IT ON I¿M OK¿. THE PATIENT HAS TRIED TO ADJUST WITH THE PATIENT PROGRAMMER (PP) BUT IT HAS NOT HELPED. THERE HAVE BEEN NO FALLS OR TRAUMA. THE PATIENT STATED ¿MY BACK IS SO BAD I DON¿T THINK IT EVEN HELPED ME TO TELL THE TRUTH. THE PAIN TO HAVE IT ON AND THE SHOOTING PAIN, I DON¿T WANT THAT¿. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) REPORTED THE CAUSE OF EVENT WAS PATIENT PERCEPTION OF PAIN IN AREA OF SI. PATIENT EXPERIENCED PAIN IN THE RIGHT BUTTOCK AND WAS TENDER OVER SI JOINT. NOT CONCERNED OF ANY STIM ISSUE. IMPEDANCES WERE NORMAL. EXPLANT PER PATIENT REQUEST, NOT USING STIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305095 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention