BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4090710 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17067
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA0GBSD, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROSTIMULATOR INS WAS MAKING A NOISE, SIMILAR TO A WEATHER RADIO GOING OFF. THIS OCCURRED IN THEIR EXAM ROOM AND HEARD THE NOISE SEVERAL TIMES. PATIENT REPORTED HAS NOT HEARD THE NOISE BEFORE, BUT SOMEONE FROM THE CLINIC (CARDIOLOGY DEPARTMENT) DID BELIEVE IT WAS COMING FROM THE NEUROSTIMULATOR. THEY ATTEMPTED TO RULE OUT BUT COULD NOT AS THEY WERE UNABLE TO HEAR THE NOISE AGAIN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570163 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR