BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1223143 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03732
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 4, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS CAPPED.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STORED EGMS REVEALED NOISE ON THE RV LEAD. THE LEAD WILL BE REPLACED WHEN THE DEVICE REACHES ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS PROGRAMMED PACING OFF TO AVOID POSSIBLE INAPPROPRIATE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention