BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT DR

    MDR report key: 3862207 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11099
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. PRODUCTS: 672625 ADAPTOR IMPLANTED: 2006 (B)(6); (B)(4) LEAD IMPLANTED: 2006 (B)(6); 0158 COMPETITOR LEAD IMPLANTED: 2003 (B)(6); 4473 LEAD IMPLANTED: 2003 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED THE SET SCREW WAS FOUND IN THE CONNECTOR BORE.

    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 DURING THE IMPLANT PROCEDURE, THE COMPETITOR LEAD EASILY REMOVED FROM PREVIOUS DEVICE DURING CHANGE OUT BUT COULD NOT FULLY SEAT THE LEAD IN THE NEW DEVICE. WHEN GOING BACK TO THE PREVIOUS DEVICE, THE LEAD SLID RIGHT BACK INTO THE HEADER WITH NO PROBLEM AT ALL. IT WAS NOTED THAT WHEN THE COMPETITOR LEAD WAS INSERTED INTO THE DEVICE, HIGH IMPEDANCE WAS MEASURED WITH NO PACING. THE DEVICE WAS ATTEMPTED AND NOT USED. ANOTHER DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342133 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR 6721M-50 LEAD