BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3181076 · Received June 20, 2013

    Report

    Report Number
    2938836-2013-02795
    Event Type
    Death
    Date Received
    June 20, 2013
    Date of Event
    May 5, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. SHOULD HAVE BEEN NO RATHER THAN YES; SHOULD HAVE BEEN NOT RETURNED TO MANUFACTURER; RESULTS CODE SHOULD HAVE BEEN (B)(4); CONCLUSION CODE SHOULD HAVE BEEN (B)(4); THE FOLLOWING DELETED: DEVICE EVALUATED BY MANUFACTURER, REASON_FOR_NO_EVAL_CODE, -RECEIVED DATE, RESULTS1.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO VENTRICULAR ARRHYTHMIA. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THE DEATH WAS DEVICE RELATED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280145 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death