BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3925892 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15293
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD WAS PROMINENT AND SUPERFICIAL ON THE SKIN. TO AVOID A POTENTIAL SKIN EROSION, THE POCKET WAS ELECTIVELY REVISED AND THE LEAD WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403478 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7122Q/65, BKC035312