BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE-FIXATION LEAD

    MDR report key: 1073551 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02445
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 18, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE DISLODGEMENT. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. DRIED BODY FLUID/TISSUE INSIDE THE HEADER AND INNER INSULATION PREVENTED NORMAL HELIX EXTENSION, AND CAUSED THE INNER COIL TO BE OVERTORQUED WHEN APPLYING TOO MANY REVOLUTIONS TRYING TO EXTEND/RETRACT THE HELIX. AFTER CLEANING AND CUTTING, THE HELIX COULD BE FULLY EXTENDED BUT NOT FULLY RETRACTED DUE TO THAT THE HELIX WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPIES DUE TO SENSING ISSUES. X-RAY CONFIRMED LEAD DISLODGEMENT. THE LEAD WAS EXPLANTED WHEN AN ATTEMPT TO REPOSITION WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE-FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7022/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention