BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3223654 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11673
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 17, 2013
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V492289, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE ¿DIDN¿T WORK¿ BECAUSE OF PLACEMENT. IT WAS NOTED THAT THE DEVICE ¿REALLY HELPED¿ WHEN IT WORKED. THE DEVICE WAS CONSEQUENTLY REPLACED. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322339 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention