BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3961595 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13599
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TWISTED HER ANKLE AND BROKE IT IN (B)(6) 2010. IT WAS NOTED THAT THE PATIENT HAD SURGERY TO REPAIR HER LIGAMENT IN HER ANKLE IN (B)(6) 2010. IT WAS NOTED THAT THE PATIENT STOPPED USING HER DEVICE FOR A WHILE AND WHEN SHE TRIED TO USE IT, IT STILL WORKED BUT AFTER A WHILE IT DIDN¿T WORK FOR HER. IT WAS NOTED THAT 6 MONTHS AFTER THE PATIENT TWISTED HER ANKLE AND BROKE IT, THE STIMULATION QUIT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439163 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR