BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 3924127 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15055
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 9, 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
    NJ, US
    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 THE PATIENT WAS PRESENTED IN THE OPERATING ROOM FOR A STANDARD DUAL CHAMBER PACEMAKER PLACEMENT. DURING THE IMPLANT PROCEDURE, THE ATRIAL LEAD DISLODGED. THE LEAD ALSO EXHIBITED LOSS OF CAPTURE AND LOSS OF SENSING. THE LEAD WAS NOT IMPLANTED AND NEW LEAD WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399804 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR