BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 3924125 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15049
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, IT WAS DIFFICULT TO INSERT THE ATRIAL LEAD INTO THE PULSE GENERATORS HEADER. A DIFFERENT LEAD COULD EASILY BE INSERTED INTO THE DEVICES HEADER AND IT WAS BELIEVED TO BE A LEAD ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399310 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1