BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2040901 · Received March 23, 2011

    Report

    Report Number
    6000153-2011-02207
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    DURING AN IMPLANT PROCEDURE, WHILE THE PHYSICIAN WAS INTRODUCING THE LEAD, FELT RESISTANCE MID-WAY DOWN THE INTRODUCER. SLIGHT PRESSURE WAS APPLIED AND THE LEAD WAS INSERTED. UPON INTRA-OPERATIVE RADIOGRAPHIC EVAL, A 90 DEGREE KINK WAS SEEN ON THE LEAD. THE LEAD WAS REMOVED AND, ON VISUAL EXAMINATION, APPEARED FRACTURED. A NEW LEAD WAS PLACED WITHOUT INCIDENT. NO INJURIES WERE REPORTED AND THE PT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MPROC, VILLALBA 3093BLUE_LEAD V601602

    Patients

    Seq Age Sex Outcome Treatment
    1