BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1080281 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04233
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 23, 2008
    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
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A "NEW AND UNIQUE" PAIN IN THE POCKET AREA. THE PT ATTEMPTED MULTIPLE TIMES TO RECHARGE THE DEVICE, BUT WAS NOT ABLE TO GET ANY COUPLING BARS. THE PT NOTED A CHANGE IN THE POCKET SITE. THE BATTERY WAS TILTED TO THE POINT WHERE THE PT COULD ONLY FEEL ONE SIDE AND NOTICED A HARD, PAINFUL LUMP ABOUT THE SIZE OF A "ROOFING NAIL" NEAR THE INS. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 55 YR Required Intervention EXTENSION MODEL 37082 LOT#NKB011466N| IMPLANTED| EXPLANED| LEAD MODEL 3487A LOT#V010371| LEAD MODEL 3777 LOT# V072746014| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 37743 LOT # NKE102945N| ACCESSORY MODEL 37752 LOT# NKA111079N| EXPLANTED| IMPLANTED