BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1648070 · Received April 1, 2010

    Report

    Report Number
    2017865-2010-01449
    Event Type
    Death
    Date Received
    April 1, 2010
    Date of Event
    January 4, 2010
    Report Date
    January 8, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    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, AND MAUDE REPORT NUMBER 1028232-2010-00012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A VF EPISODE AND WAS SHOCKED SUCCESSFULLY. THE PHYSICIAN TRIED TO CONTACT THE PATIENT FOR A CHECK UP BUT COULD NOT REACH HIM. THE FOLLOWING DAY, OUT OF RANGE LEAD IMPEDANCES WERE OBSERVED VIA HOME MONITOR. THE PHYSICIAN NOTED THAT THE PATIENT STILL COULD NOT BE REACHED. THE PATIENT PASSED AWAY LATER THAT EVENING. THE LEAD IS BEING RETAINED BY THE FUNERAL HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death