BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPL LEAD, TRANSVENOUS

    MDR report key: 3220049 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04663
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 8, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NEW INFORMATION INDICATED THE SENSE/PACE PORTION OF LEAD WAS CAPPED DURING A POCKET REVISION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING AN ALERT FOR NON-SUSTAINED LEAD NOISE. THE STORED EGMS SHOW THE OVERSENSED EVENTS ARE RANDOM WITH VARYING AMPLITUDES. THE LEAD NOISE WAS NOT REPRODUCIBLE THROUGH TESTING. THE DEVICE WAS REPROGRAMMED. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319989 SPL LEAD, TRANSVENOUS DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION SP02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR