BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR, DF4 CONNECTOR

    MDR report key: 3220038 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04503
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 29, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION. DURING EXTRACTION PROCEDURE A TEAR DEVELOPED AT THE SVC-RA JUNCTION AND THE PHYSICIAN OPENED THE CHEST TO INTERVENE. THE TEAR WAS REPAIRED SUCCESSFULLY. PATIENT IS IN STABLE CONDITION IN THE RECOVERY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321201 ELLIPSE DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 1580, RE053064, 1688T, JU095669, 6935M, TDL011396V