BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT DR

    MDR report key: 4162941 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19316
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 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
    FL, 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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DISPLAYED T WAVE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD A WEEK AFTER A DEVICE CHANGE OUT. THE OVERSENSING WAS NOTED ON A DEVICE INTERROGATION. THE PHYSICIAN ELECTED TO REOPEN THE POCKET AND INVESTIGATE FURTHER. THE DEVICE WAS NOTED TO HAVE BLOOD IN THE RV LEAD HEADER PORT. THE DEVICE WAS EXPLANTED AND REPLACED AND THE RV LEAD REMAINS 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
    639031 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DDBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R 6947M-55 LEAD, 4076-45 LEAD