BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT VR

    MDR report key: 3992216 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14885
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 28, 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
    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 THE PATIENT RECEIVED SIX INAPPROPRIATE SHOCKS FOR TWOS (T-WAVE OVERSENSING). AT TIMES THERAPY WAS WITHHELD BY THE TWOS ALGORITHM BUT THE TWOS WAS INTERMITTENT. THE DEVICE AND LEAD REMAIN 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
    470933 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DVBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Life Threatening 6935M62 LEAD