BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS VR

    MDR report key: 1050984 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01918
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 24, 2008
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF NOISE AND INAPPROPRIATE THERAPY WAS CONFIRMED BY REVIEW OF THE STORED EGM'S. THE DEVICE WAS EVALUATED AND FOUND TO FUNCTION NORMALLY. THE ROOT CAUSE OF THE NOISE AND INAPPROPRIATE THERAPY IS BELIEVED TO BE A LEAD ANOMALY. AUTOMATED TEST SYSTEM TEST WAS PERFORMED AND NO ANOMALIES WERE DETECTED.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A SHOCK WITH SEVERAL VF DETECTIONS DUE TO VENTRICULAR NOISE. NOISE WAS REPEATABLE WHEN WIGGLING THE CHEST. AFTER EXPLANTING THE DEVICE, THE PHYSICIAN UNSCREWED ALL THE CONNECTORS OF THE LEAD. THE IS-1 CONNECTOR WAS DIFFICULT TO REMOVE. BLOOD/FLUID WAS OBSERVED ON THE LEAD CONNECTOR. THE PHYSICIAN DOES NOT KNOW WHETHER THIS IS A LEAD OR CONNECTOR ISSUE. THE DEVICE AND LEAD WERE EXPLANTED.

    Description of Event or Problem · 1

    AFTER THE INITIAL REPOSITION IN (B) (6) 2007, THE PATIENT REPORTED CHEST PAIN. THE LEAD WAS FOUND TO HAVE FALLEN INTO THE SAME HOLE AS THE INITIAL PERFORATION, CAUSING ANOTHER PERFORATION. THE LEAD WAS EXPLANTED AND REPLACED WITH A PASSIVE LEAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention