BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D, DF-4 CONNECTOR

    MDR report key: 1895814 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04708
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 17, 2010
    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
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT WAS CONFIRMED IN THE LABORATORY. A LONGEVITY CALCULATION SHOWED THE BATTERY VOLTAGE WAS OUTSIDE OF NORMAL LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED ELECTRICAL SYSTEM. NO ANOMALIES WERE DETECTED. THE DEVICE WAS TEMPERATURE CYCLED AND PLACED IN A HUMIDITY CHAMBER FOR ONE WEEK. THE DEVICE SHOWED NORMAL CURRENT CONSUMPTION. THE BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. NO ANOMALIES WERE FOUND. THE CAUSE OF THE BATTERY DEPLETION WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO PREMATURE ERI AFTER BEING IMPLANTED FOR 6 MONTHS. THE PATIENT IS PACEMAKER DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE PLUS CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention