BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 3923438 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14711
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 3, 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
    AU
    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 IN THE HOSPITAL EXPERIENCING SHORTNESS OF BREATH. NOISE WAS NOTED ON THE RIGHT VENTRICULAR LEAD; CAUSING INAPPROPRIATE INHIBITION OF PACING. NOISE COULD BE REPRODUCED WITH ARM MOVEMENT. THE LEAD REMAINED IMPLANTED AND THE PATIENT WOULD BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION REPORTED STATED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR A FOLLOW UP DUE TO THE VENTRICULAR NOISE ISSUE. THE PATIENT DID NOT HAVE ANY COMPLAINTS AND WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400560 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR