BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT DR

    MDR report key: 5122753 · Received October 2, 2015

    Report

    Report Number
    3004209178-2015-19542
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS INDICATED THAT THE RETURNED DEVICE HAD A LOOSE/DETACHED SET SCREW. THE ANALYST INDICATED THAT AFTER REMOVING THE ATRIAL GROMMET IT WAS FOUND THAT THE ATRIAL SETSCREW WAS DISENGAGED SIDEWAYS. THE ATRIAL BORE WAS ABLE TO HOLD A .101 INCH PIN GAUGE AND AN IS-1 LEAD WAS FULLY INSERTED INTO THE ATRIAL BORE. THE SETSCREW WAS TIGHTENED TO ONE CLICK ON A MEDTRONIC TORQUE WRENCH AND SLIGHTLY TUGGED. THE RESULT WAS THE LEAD REMAINED IN ORIGINAL POSITION. IS-1 INSERTION GAUGE 060889 WAS INSERTED INTO THE BORE WITH NORMAL FORCE NO BINDING WAS FELT. IT WAS ALSO NOTED THAT A LEAD WAS FULLY INSERTED INTO RV BORE AND THE SETSCREW WAS TIGHTENED TO ONE CLICK ON MEDTRONIC TORQUE WRENCH AND SLIGHTLY TUGGED. THE RESULT WAS THE LEAD REMAINED IN ORIGINAL POSITION. THEREFORE IT WAS NOTED THAT BOTH OF THE GROMMETS HAD NO ISSUES FOUND.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER INITIAL IMPLANT, CHEST X-RAY CONFIRMED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD PULLED BACK. SMALL R WAVES WERE ALSO NOTED. CHEST X-RAY ALSO CONFIRMED THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED AND A LOSS OF CAPTURE AND SENSING WERE INDICATED. A LEAD REVISION PROCEDURE WAS CONDUCTED APPROXIMATELY ONE WEEK LATER. AFTER RV AND RA LEADS WERE REPOSITIONED, THE PHYSICIAN WAS UNABLE TO GET MULTIPLE SCREWDRIVERS TO SEAT IN THE SETSCREW OF THE ATRIAL PORT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD WAS EXPLANTED AND REPLACED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT APPROXIMATELY THREE WEEKS LATER, THE RA AND RV LEADS WERE REMOVED DUE TO SYSTEM INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653703 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R