BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 5992972 · Received October 3, 2016

    Report

    Report Number
    2938836-2016-12142
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF AN INABILITY TO SECURE THE LEAD INTO THE HEADER WAS NOT CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE HEADER BORES WERE EMPTY AND CONTAINED NO LEADS OR PORTIONS OF LEADS. VISUAL EXAMINATION OF THE HEADER AND LEAD BORES NOTED NO ANOMALIES. THE BORES WERE MEASURED WITH PIN GAUGES AND WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV LEAD PIN WAS BROKEN AFTER IT WAS CONNECTED IN THE DEVICE HEADER. THE DEVICE WAS NOT USED, AND DIFFERENT ONE WAS IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646898 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40QC P000030323

    Patients

    Seq Age Sex Outcome Treatment
    1 7120Q/65, (B)(4)