BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT DR

    MDR report key: 4830909 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-10850
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. ANALYSIS REVEALED A SET SCREW WITH A ROUNDED SOCKET.

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN CLAIMED HE WAS UNABLE TO ENGAGE THE ATRIAL AND VENTRICULAR SETSCREWS OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND WAS UNABLE TO MOVE THEM IN EITHER DIRECTION. DURING THE CLOSING PROCESS, NOISE WAS INDICATED ON THE ATRIAL CHANNEL. THE LEADS WERE REMOVED AND THE HEADER WAS IRRIGATED TO REMOVE BLOOD THAT HAD INGRESSED. THE ATRIAL PORT COULD NOT BE COMPLETELY CLEARED. THE PHYSICIAN THEN ATTEMPTED TO REATTACH THE LEADS BUT WAS UNSUCCESSFUL IN ATTACHING THE ATRIAL LEAD DUE TO SET SCREW PERFORMANCE. THE ICD WAS NOT USED BUT WAS REPLACED SUCCESSFULLY WITH ANOTHER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379343 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR