BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4121581 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17793
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A STAGE 2 PROCEDURE ON THE DAY OF REPORT TO PLACE THE PRIMARY CELL IN THE RIGHT SIDE TO AVOID THE LEFT SIDE POCKET WHERE THE MRSA WAS. THERE WERE NO ISSUES WITH THE SINGLE CELL THAT WAS IN THE RIGHT SIDE AND REPLACED. THE RESIDENT AND THE SURGEON PULLED ON THE BOOT AND THEY COULD VISUALIZE THE CONTACT WAS ¿STRIPPED A LITTLE¿. THEY PULLED THE BOOT TOO HARD. THE IMPEDANCES WERE RUN AT 0.7, 1.5, AND 3.0V AND THE RESULTS WERE: C-0=1602, C-1=1087, C-2=1087, C-3=1087, 0-1=1816, 0-2=1816, 0-3=1816, 1-2=35, 1-3=34, 2-3=32. THERE WAS A SHORT AND THEY WERE GOING TO PROGRAM AROUND THE COMBINATION. THE IMPEDANCES ON THE OTHER SIDE WERE NORMAL AND THE PATIENT WOULD BE PROGRAMMED USING PROGRAMS 8 AND 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601945 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR