BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2163121 · Received July 2, 2011

    Report

    Report Number
    2163121
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 2, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MEDTRONIC LEAD WAS OPENED AND NOT USED DUE TO A POSSIBLE DEFECT. BECAUSE OF ADVANCED HEART FAILURE SYMPTOMS, THE PATIENT PRESENTED TODAY FOR ELECTIVE IMPLANTATION OF A DUAL-CHAMBER CARDIAC RESYNCHRONIZATION ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY LEAD, PACING, LEFT VENTRICULAR OJX MEDTRONIC, INC. 4196-88 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR