BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 4862421 · Received June 23, 2015

    Report

    Report Number
    2017865-2015-07196
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 17, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. CHEST X-RAY WAS NORMAL. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407031 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1458Q/86 4675671

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention