BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3947228 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-13292
    Event Type
    Injury
    Date Received
    July 21, 2014
    Report Date
    July 15, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-33, LOT# V062019, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATES HER INTERSTIM EXPERIENCE HAS BEEN A COMPLETE NIGHTMARE. THE PATIENT SAYS SHE WAS IMPLANTED IN 2008 AND APPROXIMATELY FOUR MONTHS AFTER IMPLANT SHE HAD TO HAVE A REVISION DUE TO DEVICE MIGRATION. IT WAS REPORTED THAT THE DEVICE WAS FLOATING IN HER BUTTOCK. THE PATIENT STATES THAT AFTER HER REVISION IN IT WAS WORKING 'FINE'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425290 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention