BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, DF-4 CONNECTOR

    MDR report key: 2242615 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06539
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    June 10, 2011
    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 A BROKEN CONNECTION BETWEEN THE HEADER WIRE AND THE RV TIP CONNECTOR WAS NOTED. THIS WOULD CAUSE THE INABILITY TO SENSE/PACE AND THE OUT OF RANGE IMPEDANCE READINGS.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING A VIBRATORY ALERT FOR HIGH RV LEAD IMPEDANCE. INTERMITTENT VENTRICULAR SENSING AND NO CAPTURE WERE OBSERVED. CHEST X-RAY DID NOT REVEAL A LEAD ISSUE. THE PHYSICIAN N REOPENED THE POCKET. ALL MEASUREMENTS WERE NORMAL. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTIFY VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention