BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS DR

    MDR report key: 1895839 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04761
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 9, 2010
    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
    FL
    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 THE PATIENT PRESENTED TO THE ER FEELING BADLY. UPON INTERROGATION A BACKUP MESSAGE WAS DISPLAYED SHOWING THE DEVICE WAS IN BACKUP VVI MODE WITH NO DEFIB THERAPIES. THE PATIENT UNDERWENT SURGERY APPROXIMATELY 1.5 WEEKS PRIOR TO THE ER VISIT. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-239 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention