BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1050654 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01616
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 29, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    INTERMITTENT OPEN IMPEDANCE OF THE IS-1 PROXIMAL CABLE WAS EXHIBITED WHILE PERFORMING FUNCTIONAL TESTS ON THE RETURNED LEAD. VISUAL ANALYSIS REVEALED A FRACTURE OF THE COIL, 2.3CM FROM THE CONNECTOR END. VISUAL ANALYSIS CONFIRMED THAT ALL FIVE WIRES OF THE IS-1 PROXIMAL COIL WERE FRACTURED. THIS WOULD ACCOUNT FOR THE NOISE AND INAPPROPRIATE THERAPIES. THE LEAD INSULATION IS CUT 18 CM FROM THE CONNECTOR END. THIS DAMAGE IS CONSISTENT WITH THAT OCCURRING AT THE TIME OF EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSED NOISE. THE LEAD WAS REPLACED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER¿S DOWN ARROW BUTTON IS BROKEN/CRACKED. 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 ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention