BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPL LEAD, TRANSVENOUS

    MDR report key: 3892796 · Received June 24, 2014

    Report

    Report Number
    2938836-2014-12340
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT NOTIFIER WAS DELIVERED FOR LOW, HV LEAD IMPEDANCE. DEVICE POCKET WAS MANIPULATED BUT LEAD IMPEDANCE REMAINED LOW. ALL OTHER LEAD PARAMETERS ARE NORMAL. IT WAS ALSO NOTED THAT FLUID WAS PRESENT IN THE DEVICE POCKET. LEAD REMAINS IMPLANTED AND PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368458 SPL LEAD, TRANSVENOUS DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD SP01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1