BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 4231338 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18121
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    July 29, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND NORMAL LEAD CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED DIAPHRAGMATIC STIMULATION. THE NURSE COULD NOT REPRODUCED THE STIMULATION IN CLINIC. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014. INFORMATION RECEIVED ON (B)(6) 2014 NOTED THAT THE LEFT VENTRICULAR LEAD WAS EXPLANTED DUE TO HIGH CAPTURE THRESHOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714474 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention