BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT VR

    MDR report key: 3861558 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11174
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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 APPROXIMATELY FIVE MONTHS AFTER IMPLANT, THE PATIENT DEVELOPED A SYSTEMIC INFECTION. THE IMPLANTABLE CARDIAC DE FIBRILLATOR (ICD) AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343161 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DVBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R 6935M55 LEAD