BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3231276 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11885
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 18, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA093Z8, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. AN APPOINTMENT ON 2013 (B)(6) WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS STILL WEARING A PAD AND NOTED IT WAS "NOT WORKING¿. THE PATIENT HAD ONLY BEEN CHANGING THE SETTING, BUT THOUGHT THEY NEED TO CHANGE THE PROGRAM. WHEN THE PATIENT CHANGED THE SETTING, THEY WOULD JUST ¿GO UP¿. THE PROGRAM WAS ATTEMPTED TO BE CHANGED, BUT IT WOULD NOT WORK. IT WAS NOTED THE PATIENT DID REACH A 50% REDUCTION IN SYMPTOMS, BUT WAS NOT NOW. THE SCREEN ON THE PROGRAMMER WOULD NOT NAVIGATE AWAY FROM THE PROGRAM SCREEN WHEN THE PATIENT TRIED TO CHANGE PROGRAMS. THE DEVICE WAS CURRENTLY ON PROGRAM 1 AT 2.0V. TROUBLESHOOTING DID NOT RESOLVE THE SCREEN ISSUE. THE PATIENT OBTAINED NEW BATTERIES AND REPORTED THE SAME ISSUE - NOT BEING ABLE TO NAVIGATE AWAY FROM PROGRAM SCREEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330661 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1