BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3923903 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14839
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 27, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR ROUTINE FOLLOW-UP ON (B)(6) 2014. UPON INTERROGATION, THE LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE; X-RAY WAS RECOMMENDED. ON (B)(6) 2014 CHEST X-RAY CONFIRMED THAT THE LEFT VENTRICULAR LEAD HAD DISLODGED. DURING LEAD REPOSITIONING IT WAS DISCOVERED THAT THE VEIN WAS OCCLUDED. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401193 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention