BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVL LEAD, RIGHT VENTRICULAR

    MDR report key: 1050688 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01650
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    December 10, 2007
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND AN INSULATION ABRASION ON THE IS-1 CONNECTOR AT 6.5CM FROM THE CONNECTOR PIN. THE INSULATION OF THE RV CONNECTOR WAS DAMAGED AT 6.7CM FROM THE CONNECTOR PIN. BURN MARKS WERE NOTED ON THE PROXIMAL COIL AND RV COIL AT 6.5CM AND 6.7CM FROM THE CONNECTOR PIN. THE DAMAGE FOUND IS CONSISTENT WITH FRICTION TO THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN HARDWARE RESET WITH TACHY THERAPY DISABLED. THE LEAD WAS FOUND TO HAVE INSULATION DEGREDATION. THE DEVICE WAS EXPLANTED, AND THE LEAD WAS CAPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DECEASED. IT WAS NOTED THAT THE LEAD EXHIBITED A MECHANICAL PROBLEM. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVL LEAD, RIGHT VENTRICULAR DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION RV02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention