BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT DR

    MDR report key: 3992727 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14770
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    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

    (B)(4).

    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 THERE WERE MANY NSVT (NON-SUSTAINED VENTRICULAR TACHYCARDIA) EVENTS WITH TWOS (T-WAVE OVERSENSING), WHICH WERE BEING LABELED FS (FIBRILLATION SENSE) AND TS (TACHYCARDIA SENSE). THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE MANY NSVT (NON-SUSTAINED VENTRICULAR TACHYCARDIA) EVENTS WITH TWOS (T-WAVE OVERSENSING), WHICH WERE BEING LABELED FS (FIBRILLATION SENSE) AND TS (TACHYCARDIA SENSE). THE DEVICE AND LEAD REMAIN 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
    471448 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR