BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 6103220 · Received November 15, 2016

    Report

    Report Number
    2938836-2016-14225
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 14, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. INTERNAL INSULATION ABRASIONS WERE NOTED AT 13.5-14.6CM AND 12.8-13.3CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION UNDER THE RV SHOCK COIL WAS NOTED AT 6.7-8.3CM FROM THE DISTAL TIP. THE SENSING CONDUCTOR ETFE WAS ABRADED AT THIS LOCATION. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE AND SENSING ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED IN THE OPERATING ROOM FOR A LEAD EXTRACTION. LEAD INTEGRITY ALERT WAS RECEIVED. NOISE AND SUDDEN DECREASE IN SENSING AMP WERE ALSO OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POST-PROCEDURE AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752634 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7001/65 0002128119

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention