BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3090659 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-07232
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V565966, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT PROGRAMMER WAS NOT WORKING. IT WAS NOTED THAT THE PATIENT PROGRAMMER SHOWED A SCREEN WITH A CIRCLE AND TWO ARROWS. IT WAS NOTED THAT THE PATIENT'S DEVICE WAS GETTING A "SHOCK" BUT IT WAS UNCLEAR WHAT THIS MEANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROVIDER WAS UNABLE TO ADJUST STIMULATION. THE PATIENT WAS SUPPOSED TO BE 'ADJUSTED EVERY 72 HOURS' BUT THEY HADN'T BEEN ABLE TO COMMUNICATE SINCE SUNDAY. IT WAS REPORTED A POWER-ON-RESET (POR) CONDITION OCCURRED. THE MESSAGE HAD BEEN OCCURRING SINCE THE DATE OF REPORT. THE PATIENT WAS NOT HAVING ANY SYMPTOMS. IT WAS NOTED THE PATIENT WAS IN AN ASSISTED LIVING FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191934 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR