BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223689 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03563
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 19, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS. AN ABRASION WAS FOUND ON THE INSULATION AND THE TWO DF-1 RV CABLES WERE SEPARATED, AND MELTED IN THE AREA OF THE ABRASION. THE DAMAGE IS CONSISTENT WITH THAT OCCURRING DUE TO FRICTION WITH THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOCK, THE DEVICE MADE A NOISE AND A FORMATION OF SPARKS WAS SEEN. PRIOR TO EXPLANT, IT WAS NOT POSSIBLE TO MEASURE THE SHOCK IMPEDANCE. THE DEVICE HAD BURNS ON THE CAN AND THE LEAD HAD AT LEAST TWO INSULATION DEFECTS. THE DISTAL PORTION OF THE LEAD WAS LEFT IN THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES 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