BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3872908 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11863
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    March 25, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AFTER RECEIVING INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. DEVICE INTERROGATION REVEALED MULTIPLE ABORTED CHARGES DUE TO POSSIBLE OUTPUT CIRCUIT DAMAGE AND LOW HV LEAD IMPEDANCE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO COMPLICATIONS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350014 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 7000/(B)(4)