BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT DR

    MDR report key: 3992557 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14800
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    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
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 MEDICAL PRODUCTS: 407652, LEAD (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). IT WAS ALSO REPORTED THAT TURNING OFF THE WAVELET FEATURE IS THE ONLY DEVICE DISCRIMINATOR CHANGE THAT CAN BE MADE TO PREVENT INAPPROPRIATE SHOCKS. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS SHOCKED INAPPROPRIATELY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467792 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DDBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Life Threatening| R 6935M62 LEAD