BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3210791 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03308
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS NOTED AT 26.0-26.4CM FROM THE CONNECTOR END, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. THE ETFE COATING WAS INTACT AT THE SAME LOCATION. INSULATION AND CONDUCTOR DAMAGE WAS FOUND AT 24.4-26.0CM FROM THE CONNECTOR END CONSISTENT WITH CLAVICLE CRUSH DAMAGE. THE PACING/SENSING AND SVC CONDUCTORS INSULATION WERE ABRADED. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE LEAD. DURING EXPLANT, AN INSULATION ANOMALY WAS OBSERVED. LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311384 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention (B)(4)