BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPL LEAD, TRANSVENOUS

    MDR report key: 4091718 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04944
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 26, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHARGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A VIBRATORY ALERT FOR LOW OUT OF RANGE PACING LEAD IMPEDANCE. IT WAS NOT REPRODUCED WITH ISOMETRICS OR POCKET MANIPULATION. THE LEAD WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33736 SPL LEAD, TRANSVENOUS DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., INC., CRMD SP02

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR