BEUDAMED
    FDA Adverse Event Injury Summary report: N

    META DDDR

    MDR report key: 780206 · Received November 10, 2006

    Report

    Report Number
    2017865-2006-01774
    Event Type
    Injury
    Date Received
    November 10, 2006
    Date of Event
    September 11, 2006
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SYMPTOMS OF BRADYCARDIA AND PRESENTED TO THE HOSPITAL. INTERROGATION REVEALED THAT THE DEVICE WAS IN BACK-UP MODE WITH FAILURE TO CAPTURE OR PACE. A PREVIOUS FOLLOW-UP ON JULY 17, 2006, SHOWED NORMAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 META DDDR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1256 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention