BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3934689 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13012
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    March 5, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID N EU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE FOR THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY CHANGE/REPLACEMENT, THAT WHEN IT WAS TIME TO INSERT THE NEW ¿WIRE¿ IT FAILED (¿E.G. BROKE, COULDN¿T GET IT TO WORK¿). IT WAS NOTED THAT THE ORIGINAL INTENT OF THE PROCEDURE WAS TO REMOVE THE OLD INS AND WIRE AND INSERTION OF A NEW WIRE WITH A NEW BATTERY. IN ADDITION IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF URINARY RETENTION AND URGENCY. IT WAS NOTED THAT ANOTHER DEVICE WAS USED AND THAT THERE WAS NO REPORTED HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414267 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR