BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IINTERSTIM II

    MDR report key: 1890191 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-08285
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    August 4, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    INSERTED AND THEN REMOVED DUE TO FRACTURED LEAD AND HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IINTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL 3889, LOT # UNK| EXPLANTED:| IMPLANTED: