BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3190574 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10909
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT USED THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR OVER 1 YEAR. IT WAS NOTED THAT IMPEDANCE RE ADINGS WERE GREATER THAN 10000 OHMS ON ELECTRODES 8-15. IT WAS UNKNOWN WHY THE PATIENT WAS NOT USING STIMULATION OR WHY THE 8-15 TAIL WASN¿T WORKING OR HOW LONG THEY WEREN¿T WORKING. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE. THE PATIENT WAS PAIN FREE AND HAD BEEN FOR QUITE SOME TIME AND DIDN¿T REQUIRE THE USE OF THE STIMULATOR. IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL ACCIDENTALLY CUT THE LEAD DURING A DEVICE REPLACEMENT AND THIS WAS THE CAUSE OF THE ELECTRODES 8-15 NOT FUNCTIONING. IT WAS NOTED THAT EVEN WHEN THE PATIENT USED HER THERAPY, THESE ELECTRODES WERE NOT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290322 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR