BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF4 CONNECTOR

    MDR report key: 3101203 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01997
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 21, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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

    NEW INFORMATION RECEIVED NOTES THAT THE PATIENT RETURNED TO THE CLINIC AFTER RECEIVING INAPPROPRIATE ATP AND HIGH VOLTAGE THERAPY. THE DEVICE WAS REPROGRAMMED. A WEEK LATER THE PATIENT CAME BACK AND WAS HOSPITALIZED FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING INAPROPRIATE ATP AND HV THERAPY FOR ATRIAL ARRHYTHMIA. R-P TIMING WAS NOT CONSISTENT AND IT WAS DETERMINED THAT THE EVENT ORIGINATED IN THE ATRIUM. DEVICE REPROGRAMMING WAS RECOMMENDED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204514 UNIFY CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R