BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1073238 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02501
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 26, 2008
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND AN OUTER INSULATION ABRASION AT 18.5 CM FROM THE CONNECTOR, LIKELY CAUSED BY FRICTION TO THE ICD CAN. THE TWO DF-1 RV CABLES WERE EXPOSED, SEPARATED, AND MELTED IN THIS AREA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO SYNCOPE. THE DEVICE EXHIBITED HIGH IMPEDANCE. THE PATIENT BECAME UNSTABLE DURING THE EXPLANT PROCEDURE. THEREFORE, THE LEAD WAS CUT AND CAPPED. THE INSULATION APPEARED TO BE DEFECTIVE.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    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 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention