BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM TINED QUAD WITH EXT ELECTRODE, 28 CM

    MDR report key: 2211883 · Received August 10, 2011

    Report

    Report Number
    6000153-2011-06210
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MPROC - VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STAGE TWO IMPLANT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY UNSCREWING THE LEAD FROM THE PERCUTANEOUS EXTENSION. THE PHYSICIAN UNSCREWED ALL FOUR GROMMETS FROM THE PERCUTANEOUS EXTENSION, BUT STILL HAD TO TWIST AND PULL TO DISCONNECT THE LEAD FROM THE EXTENSION. WHEN THE LEAD WAS DISCONNECTED, IT HAD BROKEN BETWEEN ELECTRODES 2 AND 3. THE PHYSICIAN HAD TO REMOVE THE LEAD USED FOR STAGE 1 (MODEL 3093) AND REPLACE WITH A NEW LEAD (MODEL 3090). THE NEW LEAD WAS PLACED IN S3 AND IMPEDANCES WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM TINED QUAD WITH EXT ELECTRODE, 28 CM EZW MPROC - VILLALBA 3093 V192501

    Patients

    Seq Age Sex Outcome Treatment
    1