BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2924623 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00805
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3550-39, LOT# N288197, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS COUPLING AND OR COMMUNICATION ISSUES. USE OF ANTENNA LOCATE RESULTED IN A POWER ON RESET (POR) BEING DISPLAYED ON THE RECHARGER WHICH THEN LEAD TO NORMAL RECHARGING SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30159 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