BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 3730274 · Received April 7, 2014

    Report

    Report Number
    2938836-2014-08989
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    May 10, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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 TO THE REPORTING CRITERIA GOING FORWARD.FINAL ANALYSIS CONFIRMS COMPLAINT OF UNABLE TO INTERROGATE VIA RF TELEMETRY. THE REPORTED COMPLAINT WAS FOUND TO BE DUE TO AN ECC ERROR. NO FURTHER ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS NOT ABLE TO BE INTERROGATED VIA RF TELEMETRY. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206928 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3235-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1