BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT DR

    MDR report key: 3051050 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05769
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    February 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. CONCOMITANT PRODUCT: 5076, IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED DUE HAD HIGH IMPEDANCE AND CAPTURE THRESHOLD OF THE ATRIUM COULD NOT BE CONFIRMED. IT WAS ALSO REPORTED THAT THE DEVICE WAS SUSPECTED TO HAVE AN ATRIAL SETSCREW ISSUE. IT WAS FURTHER REPORTED THAT THERE WERE ATRIAL MARKERS WITH PROGRAMMING SET TO VVI. THEREFORE ATRIAL LEAD WAS REPOSITIONED. THE ATRIAL LEAD AND 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
    153597 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| L| R 6935M IMPLANTABLE TACHY LEAD