BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT DR

    MDR report key: 8184997 · Received December 20, 2018

    Report

    Report Number
    9614453-2018-04501
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 3, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWS
    UDI-DI
    00763000059569
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4076, 6947, IMPLANTED; (B)(6) 2011. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POST-OPERATIVE CHECK, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED IMPEDANCE AND NOISE RESULTING FROM A SUSPECTED SUPERIOR VENA CAVA (SVC) COIL FRACTURE. THE PHYSICIAN SUSPECTED A LOOSE SETSCREW OF THE DEVICE AFTER THE RECENT GENERATOR CHANGE. THE SUPERIOR VENA CAVA (SVC) COIL WAS TURNED OFF AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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
    1024247 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC EUROPE SARL DDBB1D1 00763000059569

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 6947