BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1150394 · Received September 5, 2008

    Report

    Report Number
    3004209178-2008-05464
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 12, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT RECHARGE. THE MANUFACTURER'S FIELD REPRESENTATIVE DID EXTENSIVE TROUBLESHOOTING (NOT SPECIFIED). THE DEVICE WAS REPLACED APPROX 2 MONTHS AFTER IMPLANTATION. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3778 LOT# V105310039| IMPLANTED| EXPLANTED| IMPLANTED| LEAD MODEL 3778 LOT# V104849029| IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 37081 LOT# NJB020777V| IMPLANTED| EXTENSION MODEL 37081 LOT# NJB020776V| EXPLANTED| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 37743 LOT# NKE107527N| EXPLANTED| EXPLANTED| ACCESSORY MODEL 37752 LOT# UNKNOWN