BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, DF4 CONNECTOR

    MDR report key: 3220043 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04452
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 30, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 INTERMITTENT THRESHOLD WAS OBSERVED. PATIENT WAS SYMPTOMATIC WITH CHEST PAINS. AT A SUBSEQUENT VISIT, PATIENT PRESENTED FOR NORMAL FOLLOW UP AND NOISE WAS NOTED. PHYSICIAN ELECTED TO OPEN THE POCKET AND RECONNECT THE RV LEAD INTO THE ICD. AFTER THE SET SCREW WAS TIGHTENED ALL MEASUREMENTS WERE NORMAL. FLUORO DID NOT REVEAL ANY ANOMALIES. PHYSICIAN BELIEVES THE NOISE AND INTERMITTENT THRESHOLD WAS DUE TO FLUID OR TRAPPED AIR BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319818 FORTIFY DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention