BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4250996 · Received November 6, 2014

    Report

    Report Number
    4250996
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 30, 2014
    Report Date
    November 6, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS PLACED 3 YEARS AGO IN THE PATIENT SURGICALLY IN 2011. SHE HAD AN OFFICE VISIT AT WHICH TIME THE MEDTRONIC VENDOR SCANNED THE DEVICE AND FOUND THAT THE BATTERY NEEDED TO BE REPLACED WITHIN 6 MONTHS. THE PATIENT REPORTED, AT THE SAME TIME, THAT THE BATTERY SITE IS VERY PAINFUL AND GETS VERY HOT AND RED. THE PATIENT HAD SURGERY TO REPLACE THE DEVICE WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714890 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR