BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2954652 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02444
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCTS: 1788 COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 2006; 7000 COMPETITOR IMPLANTABLE TACHY LEAD, (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD STORED EGM (ELECTROGRAM) THAT SHOWS T-WAVE OVERSENSING (TWOS) FROM A NON-MEDTRONIC LEAD DURING AN EPISODE OF SLOW VENTRICULAR TACHYCARDIA (VT) AND THE DEVICE DID NOT DISCRIMINATE. IT WAS NOTED THAT THE PATIENT HAD VERY LARGE R-WAVES. THE DEVICE REMAINS 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
    59940 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR 1056T COMPETITOR IMPLANTABLE PACING LEAD