BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952132 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00083
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS DID CONFIRM THE CUSTOMER COMMENTS THAT THE UNIT WOULD NOT TURN ON AND THAT WHEN IT WAS POWERED ON, THERE WERE LINES ACROSS THE DISPLAY SCREEN, THIS WAS ATTRIBUTED TO THE MAIN PRINTED CIRCUIT BOARD AND THE DISPLAY BEING CORRODED. ANALYSIS ALSO FOUND THE UPPER AND LOWER CASES, BATTERY FLEX AND HEART LEAD FLEX CORRODED, AND THAT THE DISPLAY WAS MISSING SEGMENTS, THAT THE UPPER AND LOWER CASES, RING COVER AND BATTERY DRAWER WERE BROKEN, THE SIDE BAIL COVERS AND SIDE BAILS WERE MISSING, THE LEAD FLEX COVER WAS CONTAMINATED AND THAT THE RING WAS BENT. IT WAS NOTED THAT DUE TO THE EXTENSIVE DAMAGE SUSTAINED BY THE UNIT, IT WAS BEING RETURNED TO THE CUSTOMER UNREPAIRED. (B)(4).

    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 WOULD NOT POWER ON. IT WAS LATER REPORTED THAT WHEN IT WAS ABLE TO BE POWERED ON, THERE WERE LINES IN THE DISPLAY SCREEN. 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
    57254 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1