BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET

    MDR report key: 6028929 · Received October 13, 2016

    Report

    Report Number
    2938836-2016-12744
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD WAS SUCCESSFULLY PLACED IN POSITION, BUT THE STYLET WAS UNABLE TO COME OUT. THE STYLET WAS CUT AND THE LEAD REMAINS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677584 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1458Q/92 A000025063

    Patients

    Seq Age Sex Outcome Treatment
    1