BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 1895821 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04726
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 6, 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
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED PREMATURE BATTERY DEPLETION WAS VERIFIED IN THE LABORATORY. WITH A NEW BATTERY ATTACHED, THE DEVICE'S FUNCTIONALITY WAS TESTED ON THE AUTOMATED ELECTRICAL TEST SYSTEM. NO ANOMALIES WERE DETECTED AND THE DEVICE MET ALL SPECIFICATIONS. THE DEVICE WAS PLACED IN A TEMPERATURE CYCLE AND A HUMIDITY CHAMBER FOR ONE WEEK. THE DEVICE'S POWER CONSUMPTION WAS FOUND TO BE NORMAL. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. ANALYSIS FOUND AN INTERNAL SHORT WITHIN THE BATTERY.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED DUE TO EXCESSIVE BATTERY DEPLETION. THE DEVICE WAS UNABLE TO COMMUNICATE AFTER LOSS OF TELEMETRY.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention