BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 1953557 · Received January 4, 2011

    Report

    Report Number
    MW5018879
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM REPORTER (B)(6) 2011: THE ST JUDE PACEMAKER PREVIOUSLY REPORTED AS HAVING DATA STORAGE ERASED MAY INDEED HAVE BEEN EXPOSED TO EMI. THIS WAS NOT INITIALLY THOUGHT TO BE THE CASE, BUT FURTHER F/U SHOWS EPISODES OF NOISE CONSISTENT WITH EMI. THE SOURCE OF EMI REMAINS UNK.

    Description of Event or Problem · 1

    PT WITH ST. JUDE MEDICAL ZEPHYR DUAL CHAMBER PACEMAKER IMPLANTED ON (B)(6) 2009. ALL STORED DATA FAILED TO RECORD - DECLARED INVALID - AT THIS AND PRIOR VISIT. ST. JUDE MEDICAL BELIEVES EMI CAUSED PROBLEM, BUT NO APPARENT SOURCE OF EMI IDENTIFIED. UNABLE TO DETERMINE AMOUNT IN A FIB OR AMOUNT PACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHYR XL DR DUAL CHAMBER PACEMAKER NVZ ST. JUDE MEDICAL 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other