BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1192065 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06375
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S DEVICE SYSTEM WAS REMOVED DUE TO A POCKET INFECTION. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention LEAD MODEL 3777| EXPLANTED| EXPLANTED| LEAD MODEL 3777| PROGRAMMER MODEL 37742| RECHARGER MODEL 37752