BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4145810 · Received October 6, 2014

    Report

    Report Number
    3004209178-2014-18385
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 16, 2014
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT# V220528, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED TO LET US KNOW HER INS (STIMULATOR) HAS BEEN TAKEN OUT. THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT. THE INS WAS TAKEN OUT ON (B)(6) 2014. THE REASON SHE HAD THE DEVICE TAKEN OUT WAS FOR THE FIRST THREE YEARS IT WAS GREAT AND THEN IT STOPPED WORKING, IT CEASED TO FUNCTION PROPERLY AND WASN¿T COMPATIBLE WITH MY SITUATION, AND THE INCONTINENCE CAME BACK. IT WAS GREAT FOR THREE YEARS, IT WAS FANTASTIC BUT THEN IT STOPPED GIVING THE PATIENT RELIEF AFTER THREE YEARS. THEY TRIED TO CHANGE THE UNIT AND THE BATTERY AND WOULDN¿T WORK FOR ME ANYMORE. ADDITIONAL INFORMATION WAS REQUESTED FROM HEALTHCARE PROVIDER. WILL SEND FOLLOW UP IF ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623189 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention