BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPL LEAD, TRANSVENOUS

    MDR report key: 3791175 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10508
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 26, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 22.3CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DECREASED R WAVES WERE NOTED ON THE RV LEAD. DURING DEVICE CHANGE-OUT FOR NORMAL ERI, AN INSULATION ANOMALY WAS OBSERVED. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268910 SPL LEAD, TRANSVENOUS DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD SP02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention