BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT DR

    MDR report key: 4163162 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19274
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 23, 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
    CO, 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. CONCOMITANT PRODUCT: 5076-45, LEAD, IMPLANTED (B)(6) 2005. (B)(4)

    Description of Event or Problem · 1

    THE PATIENT REPORTED SYMPTOMS OF "POKING AND HURTING" FROM THE AREA OF THEIR IMPLANT. THE CLINIC REPORTED THAT A POCKET REVISION WAS DONE TO RELOCATE THE DEVICE TO A MORE SUITABLE POSITION. THE DEVICE AND LEADS 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
    644192 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DDBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 6949-58 LEAD