BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3925869 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15278
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED TWIDDLERS SYNDROME AND THE LEFT VENTRICULAR LEAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. ON (B)(6) 2014 LEAD DISLODGEMENT WAS NOTED AGAIN. NO FURTHER INTERVENTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404160 QUARTET PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1458Q/92 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention