BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II DR

    MDR report key: 17517325 · Received August 11, 2023

    Report

    Report Number
    MW5124274
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    October 3, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICES RECEIVED A CALL ON 10/04/2012, FROM SALES REP. TREND FROM PRIOR DEVICE SHOWED SHOCK IMPEDANCES OF 46 OHMS (B)(6) 2011, 50 OHMS (B)(6) 2012. HIGHEST IS 55 OHMS ON (B)(6) 2012. NO PHYSICIAN OR HOSPITAL KNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869931 ATLAS II DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE MEDICAL V-268

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown