BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS VR, DF-4 CONNECTOR

    MDR report key: 3854635 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11494
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    January 29, 2014
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION SHOWED THAT PATIENT RECEIVED INAPPROPRIATE ANTI TACHY PACING THERAPY FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE RHYTHM WAS CLASSIFIED AS VT. PROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332380 CURRENT PLUS VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention