BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVL LEAD, RIGHT VENTRICULAR

    MDR report key: 1223447 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03651
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 23, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND INSULATION ABRASION AT 9.5 CM FROM THE CONNECTOR PIN ON THE IS-1 BRANCH. THE LOCATION OF THE DAMAGE IS CONSISTENT WITH THAT OF FRICTION TO THE ICDD CAN.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    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 RV-1101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1