BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 4812297 · Received June 2, 2015

    Report

    Report Number
    2017865-2015-07386
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    January 31, 2015
    Report Date
    April 6, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM FOR AN UNRELATED REASON. AN X-RAY REVEALED THAT THE LEFT VENTRICULAR LEAD WAS DISLODGED. THE PATIENT WAS ASYMPTOMATIC. THE LEAD WAS REPLACED IN (B)(6) 2015. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356141 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1458Q/86 4816791

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention