BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223480 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03630
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 15, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED IN TWO PIECES. ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED LEAD PERFORATION. A LEAD TIP STIFFNESS TEST WAS PERFORMED AND WAS FOUND TO BE WITHIN SPECIFICATION. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL. FURTHER ANALYSIS NOTED SEVERAL INSULATION ABRASIONS ON THE HELIX END POORTION, CONSISTENT WITH THAT PRODUCED BY FRICTION WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO A PERFORATION.

    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 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention