BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT VR

    MDR report key: 3991735 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14229
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DEVICE MOVES AROUND, UP TO THE COLLAR BONE AND IN THE ¿ROUND AREA¿ OF THE ARM. THE AREA IS PAINFUL AND SWOLLEN. FOLLOW UP WAS DONE WITH THE PATIENT¿S CLINIC. THE PATIENT WAS SEEN AND IT WAS NOTED THAT THE INCISION WAS CLEAN AND DRY, NO SIGN OF INFECTION. THE PATIENT WAS ENCOURAGED TO WEAR A SPORTS BRA FOR COMFORT AND TO TAKE TYLENOL IF NEED. THERE WAS NO MENTION OF DEVICE MOVEMENT IN THE CLINIC¿S NOTES. 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
    468263 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DVBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR 6935M-55 LEAD