BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3911092 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12926
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EXTERNAL INSULATION ABRASION WAS NOTED AT 32.8-33.3CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. INTERNAL INSULATION ABRASION WAS NOTED AT 7.7-7.8CM AND 12.8-13.3CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION WAS NOTED AT 9.5-11.3CM FROM THE DISTAL TIP. THE ETFE COATING WAS ABRADED AT THIS LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED TO THE OPERATING ROOM DUE TO EXTERNALIZED CONDUCTORS. NO ELECTRICAL ANOMALIES WERE DETECTED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386188 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention