BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4246218 · Received November 12, 2014

    Report

    Report Number
    3004209178-2014-21435
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT ID: 303, SERIAL# (B)(4) PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 093-28, LOT# V042306, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS DAMAGED DURING PROCEDURE. IT WAS NOTED THAT DURING THE BATTERY CHANGE, WHEN THEY DISCONNECTED THE LEAD THE INSULATION PULLED BACK ABOUT 3MM. IT WAS LATER REPORTED ON (B)(6) 2014 THAT MANUFACTURER REPRESENTATIVE WAS ON CLEAR AS TO WHAT MAY HAVE CAUSED THE BREAK AND ALL OF THE LEAD WAS EXPLANTED. THE INSTITUTION SENT EVERYTHING DOWN TO THEIR PATHOLOGY AREA, SO NOTHING WILL BE RETURNED. THE INSULATION AROUND THE LEAD BY ELECTRODE 0, AS IT ENTERS THE GENERATOR, HAD PULLED BACK EXPOSING THE ACTUAL WIRE. THE ENTIRE SYSTEM WAS REPLACED. PATIENT WAS DOING WELL. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728504 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR