BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2829057 · Received November 12, 2012

    Report

    Report Number
    3004209178-2012-10167
    Event Type
    Injury
    Date Received
    November 12, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V772374, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING TO HAVE A FLUORODYNAMIC STUDY (FUDS) "A FEW WEEKS AGO," BUT THE PATIENT HAD AN INFECTION. THE INFECTION REPORTEDLY HAD "CLEARED."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention