BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3802542 · Received May 9, 2014

    Report

    Report Number
    2017865-2014-13765
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    May 17, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED AN ANOMALY. THE LEAD WAS REPOSITIONED ON (B)(6) 2013 AND EXPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281837 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention