BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952560 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00125
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 12, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 FOUND THAT THE UPPER AND LOWER CASES WERE BROKEN, THE KNOBS WERE CRACKED, THE BATTERY DRAWER WAS DAMAGED, BOTH BATTERY LATCHES WERE BROKEN, ONE BAIL COVER WAS BROKEN, ONE BAIL COVER WAS MISSING, THE RING COVER WAS BROKEN, ONE CASE SCREW WAS MISSING, BOTH BAILS WERE MISSING, THE RING WAS BENT AND THE SERIAL NUMBER LABEL WAS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CASE WAS BROKEN. THE DEVICE WAS RETURNED FOR REPAIR. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56791 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1