BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1223393 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03662
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 8, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    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

    UPON RECEIPT, THE OUTER INSULATION WAS FOUND TO BE DAMAGED AT 8.1 CM FROM THE CONNECTOR PIN ON THE IS-1 LEG. THE DAMAGE WAS A RESULT OF FRICTION TO THE ICD CAN. THE METAL FILARS OF THE SENSING COIL WERE EXPOSED AND THIS DAMAGE CAN CAUSE OVERSENSING. THE LEAD TIP STIFFNESS WAS FOUND TO BE WITHIN SPECIFICATION. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. OTHER ABRASIION MARKS OBSERVED ON THE LEAD WERE A RESULT OF DAMAGE SUSTAINED IN THE FIELD AND ARE NOT RELATED TO THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY, DUE TO T-WAVE OVERSENSING. THE LEAD WAS REMOVED WHEN A REPOSITION WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention