BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1222421 · Received November 5, 2008

    Report

    Report Number
    3004209178-2008-07208
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    August 1, 2008
    Report Date
    October 7, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED DIFFICULTY WITH RECHARGING HER DEVICE SHORTLY AFTER THE IMPLANT. X-RAYS NOTED THE DEVICE HAD FLIPPED. THE PATIENT UNDERWENT REVISION SURGERY TO REPOSITION THE PUMP. THE PATIENT RECOVERED WITHOUT SEQUELA AND WAS ABLE TO RECHARGE AS NORMAL.

    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 PROGRAMMER MODEL 37743 LOT# NKE112987N| ACCESSORY MODEL 37752 LOT# NKA116462N| LEAD MDOEL 3778 LOT# V131611024| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD MODEL 3778 LOT# V131611022