BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3781811 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09934
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE DISTAL TIP MEASURING 53.5CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 33.8-34.2CM, 35.5-37.0CM, AND 37.2-38.0CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR PATIENT ANATOMY. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH, OUT OF RANGE PACING LEAD IMPEDANCE AND FRACTURE WERE OBSERVED. LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259874 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention