BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATLAS DR

    MDR report key: 2864094 · Received December 10, 2012

    Report

    Report Number
    2017865-2012-10532
    Event Type
    Death
    Date Received
    December 10, 2012
    Date of Event
    November 16, 2012
    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 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 PATIENT PRESENTED TO THE HOSPITAL AFTER A CARDIAC ARREST, RESOLVED BY EXTERNAL SHOCK. INTERROGATION REVEALED POSSIBLE HV LEAD DAMAGE. LOW HV IMPEDANCE WAS OBSERVED. PATIENT TRANSFERRED TO ICU WITH TACHY THERAPY DISABLED. DIAGNOSTICS REVEALED 4 VT/VF EPISODES. THE FIRST EPISODE SHOWED THAT VF DETECTION OCCURRED AND A 36J SHOCK WAS DELIVERED BUT SINUS RHYTHM WAS NOT RESTORED. NO FURTHER CHARGES WERE NOTED. PATIENT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-242 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 1580/65, (B)(4)