BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4812330 · Received June 2, 2015

    Report

    Report Number
    2017865-2015-07493
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 2, 2015
    Report Date
    May 2, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT OVERSENSING HAD BEEN OBSERVED ON THE RIGHT VENTRICULAR LEAD WHICH RESULTED IN PACING INHIBITION. ASYSTOLIC PERIODS WERE OBSERVED DURING MONITORING BUT NOT SEEN VIA STORED ELECTROCARDIOGRAMS. NO PATIENT SYMPTOMS WERE REPORTED. THE PATIENT WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356286 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 A000004330

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR