BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET

    MDR report key: 4873542 · Received June 27, 2015

    Report

    Report Number
    2017865-2015-07298
    Event Type
    Malfunction
    Date Received
    June 27, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 24, 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 PATIENT PRESENTED TO THE EMERGENCY ROOM EXPERIENCING DIAPHRAGMATIC STIMULATION. A LOSS OF CAPTURE WAS OBSERVED ON THE LEFT VENTRICULAR LEAD. X-RAY IMAGING REVEALED THAT THE LEAD HAD DISLODGED. NO INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417107 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1458Q/86 A000002520

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other