BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 1736079 · Received June 17, 2010

    Report

    Report Number
    1220908-2010-01601
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 2, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A (B)(6), MALE, BRADYCARDIAC PATIENT THE DEVICE WAS UNABLE TO CAPTURE THE PT'S HEART RHYTHM. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death