BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5166181 · Received October 21, 2015

    Report

    Report Number
    3004209178-2015-21153
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Report Date
    September 25, 2015
    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: 041829, LOT# N167109, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3889-28, LOT# V514031, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT EXPERIENCED A LOSS OR CHANGE OF THERAPY. THE PATIENT HAD TO WEAR A DIAPER AND WAS WETTING HIMSELF. IT STOPPED WORKING 6 MONTHS AGO AND THE PATIENT DID NOT FEEL STIMULATION. THE INDICATION FOR USE FOR THIS PATIENT WAS URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697700 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1