BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1830901 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03254
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 30, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. ONLY A PARTIAL LEAD WAS RETURNED, MEASURING 13CM FROM THE CONNECTOR PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING MULTIPLE INAPPROPRIATE SHOCKS. THE STORED EGMS SHOWED NOISE ON THE LEAD. LEAD IMPEDANCE, CAPTURE AND SENSING WERE STABLE. THE LEAD WAS EXPLANTED AND 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 1581/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention