BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE QUADRA

    MDR report key: 3891137 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03594
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    May 5, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 TO THE REPORTING CRITERIA GOING FORWARD. THE REPORTED FIELD EVENT OF TELEMETRY ANOMALY WAS CONFIRMED VIA REVIEW OF THE DEVICE IMAGE IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH. ANALYSIS FOUND THAT THE CAUSE OF THE ANOMALY WAS AN RF MODULE COMPONENT ARRAY ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE DEVICE WAS NOT ABLE TO BE INTERROGATED. A NEW ICD WAS USED AND TELEMETRY WAS NORMAL. THIS DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31456 PROMOTE QUADRA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK NIK ST. JUDE MEDICAL INC., CRMD CD3239-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1