BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 113560 · Received August 18, 1997

    Report

    Report Number
    2182863-1997-00004
    Event Type
    Malfunction
    Date Received
    August 18, 1997
    Date of Event
    July 19, 1997
    Report Date
    August 18, 1997
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON JULY 19, 1997 THE PHYSICIAN NOTED INTERMITTENT VENTRICULAR NON-CAPTURE AND A LEAD REVISION (REPOSITIONING) WAS NECESSARY. ON JULY 21, 1997 THE ECG SHOWED INTERMITTENT FAILURE TO CAPTURE. THE LEAD WAS REPLACED ON JULY 22, 1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant VENTRICULAR LEAD DTB ELA MEDICAL, S.A. BT46 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention