BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4323248 · Received December 11, 2014

    Report

    Report Number
    3004209178-2014-23793
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 22, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# VA0PC4H, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SETTINGS THAT THE PATIENT LEFT THE HOSPITAL ON BECAME VERY UNCOMFORTABLE AND THE PATIENT COULD BARELY WALK OR SIT. WHEN THEY WOULD LEAN OR REACH FOR SOMETHING IT WAS UNCOMFORTABLE. THIS CAME ON GRADUALLY, BUT THEN THE PATIENT STATED THAT ACTUALLY IN 1 WAY IT CAME ON SUDDENLY BECAUSE WHEN THEY WENT TO GET INTO THEIR SPOUSE¿S CAR, IT WAS LIKE ¿OH I CAN¿T SIT DOWN.¿ THE PATIENT SHUT IT OFF THAT NIGHT WHEN THEY GOT HOME. THE PATIENT NOTIFIED THEIR MANUFACTURER REPRESENTATIVE OF THE ISSUES 2 DAYS AFTER IMPLANT. OVER THE PHONE THEY WALKED THE PATIENT THOUGH CHANGING SOME OF THE SETTINGS TO ADDRESS THE DISCOMFORT. THEY GOT IT UP AND RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805713 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR