BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 4860823 · Received June 22, 2015

    Report

    Report Number
    2017865-2015-07396
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    April 27, 2015
    Report Date
    May 9, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404363 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1458Q/86 4855456

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention