BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3901105 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12687
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A CONNECTOR ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. THE REPORTED FIELD EVENT OF HIGH PACING LEAD IMPEDANCE WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND TEST LEADS WERE INSERTED SUCCESSFULLY AND AN IMPEDANCE ANOMALY WAS NOTED. FURTHER EVALUATION INDICATED THERE WAS AN ANOMALOUS COMPONENT ON THE HYBRID. THE CAUSE OF THE HIGH PACING LEAD IMPEDANCE WAS DUE TO AN ANOMALOUS COMPONENT ON THE HYBRID.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A CONNECTOR ANOMALY WAS OBSERVED. WHEN THE LEAD WAS CONNECTED TO THE DEVICE, HIGH, OUT OF RANGE PACING LEAD IMPEDANCE WAS OBSERVED. THE DEVICE WAS NOT IMPLANTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379328 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR