BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, DF-4 CONNECTOR

    MDR report key: 4760354 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04722
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    March 27, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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 VENTRICULAR PACE ON THE T-WAVE RESULTED IN VENTRICULAR FIBRILLATION. IT WAS RECOMMENDED TO PROGRAM THE ATRIAL PACE ON PVC ALGORITHM OFF SINCE AP WAS BLANKING VENTRICULAR SENSE, HOWEVER, THE PHYSICIAN ELECTED TO PROGRAM THE MODE TO VVI AT 40 PPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303665 CURRENT PLUS DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention