BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2902685 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00331
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. NO ELECTRICAL ANOMALIES WERE DETECTED. THE LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THE PATIENT HAD SOME BLOOD LOSS FROM THE EXTRACTION SITE, WHICH REQUIRED TRANSFUSION INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9571 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention