BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT DR

    MDR report key: 2955119 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-01873
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    June 15, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PRODUCT: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED FEELING THEIR HEART BEING FAST. AN EVALUATION OF THE ELECTROGRAM FROM THE REMOTE MONITORING TRANSMISSION SHOWED THE DEVICE WAS CALLING P-WAVES AS ATRIAL REFRACTORY AND WHEN THE ATRIAL PACE OCCURRED IT WAS AT THE SAME TIME AS THE VENTRICULAR SENSING. THE DEVICE AUTO POST VENTRICULAR ATRIAL REFRACTORY PERIOD SETTING WAS MAINTAINING A WINDOW WHICH WAS PREVENTING THE P-WAVE FROM BEING SENSED. THE DEVICE IS STILL 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
    58870 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR 6947 IMPLANTABLE TACHY LEAD