BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVL ADX

    MDR report key: 1223603 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03592
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 13, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SEVERAL ABORTED AND DELIVERED THERAPIES, DUE TO NOISE ON THE LEAD. THE NOISE WAS NOT REPRODUCED WITH ISOMETRICS AND POCKET MANIPULATION. SENSING, IMPEDANCE, AND CAPTURE WERE ALL S TABLE. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVL ADX DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1559/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention