BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, DF4 CONNECTOR

    MDR report key: 3090176 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01177
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 3, 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
    NY
    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 AFTER EXPERIENCING MULTIPLE SHOCKS. THE DEVICE WAS FOUND TO BE IN BACK-UP VVI MODE MOST LIKELY DUE TO A DEPLETED BATTERY. THE PATIENT WAS INTUBATED AND PLACED ON A VENTILATOR. SESSION RECORDS REVEALED THE PATIENT WAS EXPERIENCING INCESSANT VT AND VF AND RECEIVING A SHOCK ABOUT EVERY MINUTE. ANTI- ARRHYTHMICS WERE EFFECTIVE IN CONTROLLING THE PATIENTS RHYTHM. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191261 CURRENT PLUS DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention