BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT VR

    MDR report key: 1861774 · Received October 8, 2010

    Report

    Report Number
    6000094-2010-01872
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    June 11, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAPTURE MANAGEMENT WARNING CONTAINS CONFUSING INFORMATION FROM A TRANSMISSION OF A PATIENT WITH A PROTECTA CONNECTED TO THE CARELINK NETWORK. THIS OBSERVATION IS RELATED TO THE SAFETY MARGIN OF THE RV-CAPTURE MANAGEMENT. THE OBSERVATION SHOWS THAT THE SAFETY MARGIN IS AT 2.7 VOLT, WHILE THE MINIMAL ADAPTED IS PROGRAMMED AT 2 V AND THE MARGIN AT 2X. THE ACTUAL THRESHOLD IS 0.75 V. THE OBSERVATION ADVISES REPROGRAMMING THE SAFETY MARGIN TO E.G. 3X OR DECREASE THE MINIMAL ADAPTED TO E.G. 1.5 V. THE COMPLAINANT SUGGESTS THAT WHEN USING THE NOMINAL SETTINGS OF THE CAPTURE MANAGEMENT ALGORITHM, DO NOT DISPLAY THIS WARNING/OBSERVATION SINCE THIS WARNING IS VERY CONFUSING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D354VRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other