BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT DR

    MDR report key: 3861876 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11140
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 PRODUCT: 6935M-62 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT AFTER GOING THROUGH AIRPORT SECURITY, THE PATIENT HAS BEEN FEELING TIRED AND THE DEVICE HAS BEEN "BEEPING EVERY MORNING AROUND 9:00AM." THE PATIENT HAD CONTACTED THE PHYSICIAN AND SENT A REMOTE MONITORING TRANSMISSION, HOWEVER WHEN THE PHYSICIAN'S OFFICE WAS CONTACTED, NO FURTHER INFORMATION COULD BE OBTAINED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339908 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DDBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR 4076-52 LEAD