BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 5416375 · Received February 8, 2016

    Report

    Report Number
    3007566237-2016-00615
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Report Date
    January 12, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 9 7714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4). ANALYSIS OF THE DESKTOP CHARGER, S/N (B)(4), FOUND A BROKEN DESKTOP CONNECTOR.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THE METAL TIP ON THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) CONNECTOR PIN WAS BROKEN. AS A RESULT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WENT DEAD AS THEY WERE UNABLE TO CHARGE. THEY ALSO NOTED THAT THEY WERE UNABLE TO TURN IT OFF AND IT FELT LIKE IT WAS "TOO MUCH". IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73885 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37761

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR