BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951391 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00003
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN. IT ALSO FOUND THAT THE LOWER CASE WAS BROKEN, THE RING COVER AND TWO SIDE BAIL COVERS WERE BROKEN, THE RING AND TWO SIDE BAILS WERE MISSING AND THE KEYBOARD PAD WAS CONTAMINATED AS WAS THE HEART LEAD FLEX. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT DURING ROUTINE TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), THE BIOMEDICAL ENGINEER FOUND THAT THE OUTPUT CONNECTORS WERE BROKEN. THEREFORE, THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56968 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1