BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5223913 · Received November 15, 2015

    Report

    Report Number
    3004209178-2015-22849
    Event Type
    Malfunction
    Date Received
    November 15, 2015
    Date of Event
    October 26, 2015
    Report Date
    October 26, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT # V161679, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED GETTING A WARNING POWER ON RESET (POR). THERE WERE NO PATIENT SYMPTOMS REPORTED. THE PATIENT WAS INDICATED FOR INTERSTIM-OTHER. NO FURTHER INFORMATION WAS PROVIDED ABOUT THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754569 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR