BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1001529 · Received February 21, 2008

    Report

    Report Number
    3004209178-2008-00808
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 23, 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 MFR REPRESENTATIVE REPORTED THE PT'S SYSTEM WAS REMOVED DUE TO INFECTION. ADDITIONAL INFO HAS BEEN REQUESTED BY MEDTRONIC FROM THE HEALTH CARE PROFESSIONAL REGARDING THE REPORTED EVENT. A SUPPLEMENTAL MDR FOLLOW-UP REPORT WILL BE SENT TO THE FDA IF ADDITIONAL INFO IS RECEIVED.

    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 YR Required Intervention EXTENSION MODEL 37081| LOT# N129808003| LEAD MODEL 39565| LOT# NJB020487V| EXPLANTED:| LOT#NJB024263V| EXTENSION MODEL 37081| EXPLANTED:| EXPLANTED: