BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT VR

    MDR report key: 4830130 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-10950
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 25, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A FEW DAYS OF THE DEVICE IMPLANT, THE PATIENT HAD A TWENTY MINUTE EPISODE OF VENTRICULAR TACHYCARDIA (VT) AND WAVELET WITHHELD THERAPY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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
    377134 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DVBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR 6935M55 LEAD