BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4231440 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18202
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 16, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND A COMPLETE LEAD WAS RETURNED. THE INSULATION WAS OUT OF SPECIFICATION AT 2.714 MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, IT WAS DIFFICULT TO INSERT THE VENTRICULAR LEAD INTO CONNECTOR OF THE PULSE GENERATOR. THE LEAD WAS REMOVED AND IT WAS NOTED THAT THE TIP OF THE LEAD WAS DAMAGED. THE LEAD WAS NOT USED AND A NEW LEAD WAS PLACED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713501 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR PM2240, 2980313,