BEUDAMED
    FDA Adverse Event Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1895589 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04357
    Date Received
    November 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND AN INSIDE OUT ABRASION BETWEEN AT 9CM AND 10CM FROM THE HELIX AND THE IS-1 CABLES WERE EXPOSED. VISUAL INSPECTION OF THE RV SHOCK COIL SHOWED MULTIPLE INSIDE OUT ABRASIONS UNDERNEATH THE RV SHOCK COIL. THE INSULATION WAS ABRADED THROUGH AND EXPOSED THE DISTAL COIL AT 5.5CM FROM THE HELIX. THE ETFE COATING ON ONE OF THE RV CABLES WAS ABRADED AT THE SAME LOCATION.

    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

    A DISTRIBUTOR (B)(4) FORWARDED INFO TO THE MANUFACTURER IN REGARD TO A REPORTED ADVERSE EVENT INVOLVING A TRILOGY 100 VENTILATOR. ACCORDING TO THE DISTRIBUTOR, A (B)(6) INFANT WHO HAD BEEN RECEIVING CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) THERAPY VIA THE TRILOGY 100 VENTILATOR EXPIRED ON (B)(6) 2010. THE CAUSE OF THE DEATH HAS YET TO BE DETERMINED. THERE DOES NOT APPEAR TO BE AN ALLEGATION THE TRILOGY 100 MALFUNCTIONED DURING THE REPORTED EVENT. A GETEMED INFANT APNEA MONITOR WAS ALSO REPORTED TO BE IN USE AT THE TIME OF THE EVENT. THE DEVICES ARE CORRECTLY IN THE POSSESSION OF THE AUTHORITIES AND A FOLLOW-UP REPORT WILL BE FILED WHEN ADDITIONAL INFO IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO OVERSENSING. REVIEW OF THE STORED EGMS SHOWED INTERMITTENT NOISE ON THE VENTRICULAR SENSE/PACE CHANNEL DUE TO SUSPECTED LEAD MICRO-FRACTURES. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/60

    Patients

    Seq Age Sex Outcome Treatment
    1