BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 1050932 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01871
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    January 17, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT PRESENTED 2 DAYS POST IMPLANT WITH HEMATOMA. POCKET WAS DRAINED. PATIENT RETURNED 3 DAYS LATER AND SITE LOOKED WELL. LATER THAT DAY, PATIENT WAS IN CAR COLLISION AND SUSTAINED A MILD CARDIAC CONTUSION. INAPPROPRIATE THERAPY DUE TO OVERSENSING WAS ALSO NOTED. TWO WEEKS LATER, PATIENT HAD SUDDEN ONSET OF BLEEDING AT THE SITE. THE ENTIRE SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II HF CRT-D NO BNCN FOUND FOR THIS DEVICE NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-365 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention