BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D. DF-4 CONNECTOR

    MDR report key: 1831088 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03619
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 22, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P03005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4) - REVIEW OF QUALITY RECORDS.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 311 MG/DL ON ADVANTAGE SYSTEM 1, 119 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFY CRT-D. DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 7120Q/65, (B)(4), 1699TC/52, (B)(4)