BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3590980 · Received January 24, 2014

    Report

    Report Number
    3004209178-2014-01109
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Report Date
    January 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 399930, LOT# V011456, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 370836, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S FIRST IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANT WORKED SUCCESSFULLY FOR ABOUT 4 YEARS BUT EVERY OTHER INS THAT THEY HAVE HAD SINCE THAT TIME HAD NOT WORKED. IT WAS NOTED SINCE THEN THE PATIENT HAS HAD 2 SETS OF CABLES AND 2 SETS OF PADDLES AND THEY¿VE HAD AN INS ¿IN THEIR GUT¿ THAT HADN¿T WORKED FOR WAY OVER A YEAR AND A HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57719 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR