BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT DR

    MDR report key: 4163301 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19264
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED A LOOSE/DETACHED SET SCREW. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ENGAGE THE SET SCREW WITH THE WRENCH DURING THE INITIAL IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD WAS ATTEMPTED NOT USED; ANOTHER ICD WAS CHOSEN AND USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643367 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR