BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2101709 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03414
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD MIGRATED. THE PATIENT ALSO HAD PAIN ON THE LOWER EDGE OF THE NEUROSTIMULATOR. THE PAIN WAS INDUCED WHEN PRESSING ON THE DEVICE, REGARDLESS OF WHETHER THE DEVICE WAS ON OR OFF. IMPEDANCES WERE NORMAL AND WERE IN THE 500-600 OHM RANGE. THE PATIENT WAS PLANNING TO UNDERGO REVISION FOR THE LEAD MIGRATION; THERE WAS A POTENTIAL THAT THE POCKET MAY ALSO BE MOVED TO AVOID PAIN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORY: MODEL 37752, LOT# NKA133190N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39286-65, LOT# N217352003| PROGRAMMER: MODEL 37743, LOT# NKE136819N