BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 1830993 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03661
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 19, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HIGH VOLTAGE OUTPUT CIRCUITRY WAS FOUND DAMAGED AND BELIEVED TO HAVE RESULTED FROM A LEAD ANOMALY.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 311 MG/DL ON ADVANTAGE SYSTEM 1, 119 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER FEELING DEVICE THERAPY. UPON INTERROGATION, AN ALERT STATED POSSIBLE OUTPUT CIRCUIT DAMAGE AND THE HVLI MEASURED LOW. THE DIAGNOSTICS SHOWED MULTIPLE ABORTED CHARGES DUE TO THE POSSIBLE OUTPUT CIRCUIT DAMAGE. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 1580/65 (B)(4)