BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT DR

    MDR report key: 2812860 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06227
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR [RV] LEAD WAS T WAVE OVERSENSING (TWOS]. IT WAS ALSO REPORTED THAT THE TWOS CAUSED THE DEVICE TO START VENTRICULAR EPISODES THAT SELF-TERMINATE, WHICH IN TURN CAUSED THE DEVICE TO COME OUT OF MANAGED VENTRICULAR PACING [MVP] MODE AND ENTER DDDR MODE. ONCE IN DDDR MODE, THE VENTRICULAR EVENTS WERE FALLING WITHIN THE SAFETY PACE WINDOW RESULTING IN VENTRICULAR SAFETY PACING. THE RV LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other 4076 IMPLANTABLE PACING LEAD