BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4240022 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21213
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# VA0KA5J, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHE WAS ¿RUN OVER BY A COW ABOUT THREE WEEKS AGO.¿ WHEN HER PAIN STIMULATION DEVICE WAS OFF SHE INCREASED HER URINARY DEVICE AND WAS FEELING STIMULATION DOWN TOWARDS HER LEFT ¿BUTT CHEEK.¿ HOWEVER, SHE USUALLY DID NOT FEEL STIMULATION FROM THIS DEVICE. THE PATIENT ¿KIND OF¿ NOTICED A CHANGE IN HER SYMPTOMS. SOMETIMES IT FELT LIKE HER BLADDER DID NOT EMPTY COMPLETELY AND LIKE SHE WAS STARTING TO GET A BLADDER INFECTION. NO INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723993 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention