BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223666 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03575
    Event Type
    Injury
    Date Received
    November 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    SEVEN MONTHS AFTER IMPLANT, A HOME MONITORING EVENT REPORTED 6 EPISODES IN THE VF ZONE, 2 SUCCESSFUL SHOCKS, 6 DUMPED SHOCKS, AND 21 CAPACITOR CHARGING CYCLES WITHOUT SUCCESSFUL TERMINATION. PATIENT NOTICED 2 SHOCKS, BUT THE CLINIC WAS NOT NOTIFIED. LOW IMPEDANCE WAS OBSERVED WHEN PATIENT CAME IN FOR FOLLOW-UP. X-RAY DID NOT SHOW ANY SIGNS OF LEAD FAILURE. HOWEVER, DURING THE PROCEDURE, AN INSULATION ANOMALY WAS OBSERVED. THE LEAD WAS REPLACED.

    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 1580 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention