BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1171211 · Received September 22, 2008

    Report

    Report Number
    3004209178-2008-05999
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    March 19, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION IN 2008. FURTHER INFORMATION IS BEING REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention EXPLANTED:| LEAD MODEL 3889 LOT# J0405967V| IMPLANTED: