BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO

    MDR report key: 1010520 · Received February 7, 2008

    Report

    Report Number
    1010520
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 7, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING POOR LEAD SENSING WITH THE MAXIMO SINGLE CHAMBER PACEMAKER. NO SYMPTOMS AT THIS TIME, HOWEVER, DUE TO THE SEVERITY OF THE PATIENT'S PAST V-TACH, THE PHYSICIAN FELT THE NEED TO REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO IMPLANTED CARDIAC DEFIBRILLATOR (ICD) LWS MEDTRONIC, INC. VR7232 CX *
    2 FIDELIS LEAD, ICD LWS MEDTRONIC, INC. 6949-58 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR CARDIAC DRUGS| CARDIAC DRUGS