BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951663 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00054
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE DISPLAY WAS OUT OF SPECIFICATION AND CONTAMINATED. IT WAS ALSO NOTED THAT THE BATTERY FLEX, LOWER CASE, UPPER CASE WERE CORRODED AND CONTAMINATED, AND ONE SIDE BAIL COVER AND THE BATTERY DRAWER WERE BROKEN. THE DISPLAY ASSEMBLY WAS FURTHER ANALYZED. THIS ANALYSIS CONFIRMED THE ERRONEOUS DEVICE TURN ON CAUSED BY A SHORT BETWEEN A CONNECTOR ON THE CIRCUIT BOARD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD MOISTURE INSIDE (SOURCE UNKNOWN) AND THAT WHEN A BATTERY WAS INSTALLED THE GENERATOR TURNED ON WITHOUT THE POWER BUTTON BEING PUSHED. IT WAS ALSO REQUESTED THAT THE GENERATOR BE CALIBRATED. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56054 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1