BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR

    MDR report key: 3101143 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01919
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    February 28, 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
    CO
    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 A PATIENT PRESENTED IN THE HOSPITAL EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE ATP AND HV THERAPY. ATRIAL TACHY WITH RAPID VENTRICULAR RESPONSE WAS OBSERVED. REPROGRAMMING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204030 CURRENT PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention