BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3900852 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12244
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3889-28, LOT# VA081HA, MPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE HAD NOT WORKED FOR THE PATIENT SINCE IMPLANT AND THEY HAVE HAD ¿NUMEROUS¿ INFECTIONS AS WELL. THE DEVICE WAS ¿USELESS¿ AND THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT WAS INQUIRING IF IT COULD BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376447 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention