BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1063679 · Received June 19, 2008

    Report

    Report Number
    3004209178-2008-03367
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    October 1, 2007
    Report Date
    May 20, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S INTERSTIM DEVICE STOPPED WORKING. THE DEVICE SITE IS PAINFUL WHEN THE PATIENT SITS. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3093| LOT # UNKNOWN| PAIN MEDICATIONS| EXPLANTED:| PROGRAMMER MODEL 3037 LOT# NJD033921N