BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA, CRT-D, DF-4 CONNECTOR

    MDR report key: 3220153 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04550
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE PROGRAMMER UPON RECEIPT. LOW BATTERY VOLTAGE WAS OBSERVED. WITH AN EXTERNAL POWER SUPPLY ATTACHED, THE DEVICE FUNCTIONED NORMALLY; NO HIGH CURRENT WAS DETECTED DURING TESTING AND THE POWER CONSUMPTION WAS NORMAL. A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE BELOW THE EXPECTED LIMITS. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALY WAS FOUND. THE CAUSE OF THE BATTERY DEPLETION REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO CAPTURE WAS OBSERVED AND THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320189 UNIFY QUADRA, CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3235-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention