BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 3890380 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03607
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    October 12, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT OT THE REPORTING CRITERIA GOING FORWARD. EVALUATION: THE REPORTED FIELD EVENT OF CAPTURE ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE FUNCTIONED NORMALLY WHEN TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT. THE CAUSE O THE CAPTURE ANOMALY WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT VENTRICULAR THRESHOLD HAD GRADUALLY INCREASED OVER A YEAR TO NO CAPTURE AT MAX OUTPUT. ALONG WITH THE LEAD, THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30418 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC., CRMD CD3231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 1158T/75, (B)(4)