BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3981582 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13982
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE STOPPED WORKING AND MALFUNCTIONED. THE DEVICE WORKED FOR 3 MONTHS AND THEN ALL OF A SUDDEN IT STARTED ¿NOT WORKING¿. THE CHANGE WAS THOUGHT TO BE GRADUAL. IN DECEMBER/JANUARY IT GRADUALLY STOPPED WORKING AND THEN BY FEBRUARY IT WAS NOT EFFECTIVE ANYMORE. IT JUST MALFUNCTIONED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456845 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention