BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2890049 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10757
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    October 19, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS FOUND AT 20.5-20.8CM AND 21.3-21.7CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. INTERNAL INSULATION ABRASION WAS FOUND AT 7.9-8.5CM FROM THE TIP ELECTRODE. THE ETFE COATING WAS INTACT AT ALL LOCATIONS. THE OBSERVATION FROM THE FIELD OF A FRACTURE COULD NOT BE CONFIRMED IN THE LABORATORY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT, LEAD FRACTURE WAS OBSERVED. NO ELECTRICAL ANOMALIES WERE NOTED. LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR