BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3419123 · Received October 18, 2013

    Report

    Report Number
    3004209178-2013-19346
    Event Type
    Injury
    Date Received
    October 18, 2013
    Report Date
    September 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V242434, IMPLANTED: 2009 (B)(6), EXPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEADS WERE BROKEN AND SHE HAD THE DEVICE REPLACED. IT WAS STATED THE WIRE/LEADS BREAK TOO EASILY/FAST AND THEY SHOULD BE STRONGER. IT WAS REPORTED, THE PATIENT HAD LEAD WIRE BREAKS WITH HER IMPLANT AND THE DOCTOR WAS NOT ABLE TO REMOVE THE ENTIRE LEAD AND THERE WERE STILL LEAD WIRES FROM THE IMPLANT IMBEDDED IN SCAR TISSUE. IT WAS NOTED AT LEAST TWO LEADS WERE LEFT IN PLACE AND WAS CONCERNED ABOUT NEEDING AN MRI IN THE FUTURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR REPRESENTATIVE. IT WAS NOTED THE WIRES BROKE THE FIRST TIME DUE TO A FALL SO SHE UNDERSTOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535922 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention