BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951441 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00005
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 2, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT OF LOWER DISPLAY NOT WORKING. IT WAS CONFIRMED THAT THE UPPER AND LOWER CASES WERE BROKEN. IT WAS ALSO NOTED THAT THE MAIN PRINTED CIRCUIT BOARD AND DISPLAY WERE CORRODED AND CONTAMINATED, ONE SIDE BAIL COVER WAS MISSING AND ONE BAIL COVER WAS BROKEN, THE RING COVER, HEART BLOCK, HEART WIRE CONTACTS, BATTERY DRAWER AND HEART LEAD FLEX WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE LEAD FLEX COVER WAS CORRODED, ONE SIDE BAIL WAS MISSING, ONE RING BAIL WAS BENT AND THE KEYBOARD WAS SCRATCHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOWER DISPLAY OF THE EXTERNAL PULSE GENERATOR (EPG) WAS NOT WORKING, AND THE CASE HAD A SMALL CRACK. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55888 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1