BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC PLUS VR

    MDR report key: 2984327 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00602
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 18, 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
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF HIGH VOLTAGE LEAD IMPEDANCE WAS CONFIRMED IN THE LABORATORY. AN ARC MARK WAS OBSERVED ON THE ICD CAN. FURTHER EVALUATION OF THE ARC MARK INDICATED THE PRESENCE OF LEAD MATERIAL. THE DAMAGE FOUND IS CONSISTENT WITH THAT CAUSED BY ARCING BETWEEN THE HV CONDUCTOR AND THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP, SESSION RECORDS REVEALED AN ALERT FOR LOW HV LEAD IMPEDANCE AND ABORTED SHOCKS. ATTEMPTS TO TEST THE LEAD IMPEDANCE WERE UNSUCCESSFUL. THE DEVICE WAS FOUND TO BE AT ERI AND EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86111 EPIC PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-196 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR (B)(4), (B)(4)