BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 3924200 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15126
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 23, 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
    PA, 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 PRESENTED TO THE HOSPITAL EXPERIENCING BRADYCARDIA WHILE IN A PRESYNCOPAL STATE. INTERROGATION SHOWED A HIGH CAPTURE THRESHOLD WITH AN INTERMITTENT LOSS OF CAPTURE. A HIGH IMPEDANCE MEASUREMENT WAS NOTED TO HAVE OCCURRED ON (B)(6) 2013. THE LEADS OUTPUT CONFIGURATION WAS REPROGRAMMED AND THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399829 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR