BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERSTIM

    MDR report key: 727351 · Received June 15, 2006

    Report

    Report Number
    3004209178-2006-00980
    Event Type
    Other
    Date Received
    June 15, 2006
    Date of Event
    May 19, 2006
    Report Date
    May 19, 2006
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO MEDREL
    Product Code
    EZW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC INC. FOR EVALUATION. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE HCP.

    Description of Event or Problem · 1

    THE PATIENTS INTERSTIM NEUROSTIMULATOR SYSTEM WAS EXPLANTED DUE TO A WOUND INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| O LEAD MODEL 3889 LOT# J0519439V| IMPLANTED: 2005| EXPLANTED: 2006| EXTENSION MODEL 3095 LOT# NAH021175V| IMPLANTED: 2005| EXPLANTED: 2006