BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA S VR

    MDR report key: 3990866 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01748
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE RETURNED DEVICE INDICATED AN INCONCLUSIVE RESULT FOR AN INTEGRATED CIRCUIT. THE ANALYST COMMENTED THAT THEY WERE UNABLE TO OBTAIN TELEMETRY C AT PRELIMINARY ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT PROCEDURE THE WIRELESS TELEMETRY ON THE DEVICE WAS TESTED AND THERE WAS NOISY TELEMETRY WITH THE DEVICE. A NEW PROGRAMMER WAS USED AND THE DEVICE TELEMETRY WAS STILL NOISY. A NEW DEVICE WAS INTERROGATED AND THERE WERE NO WIRELESS TELEMETRY ISSUES. THE ORIGINAL DEVICE WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470168 EVERA S VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND DVBC3D4

    Patients

    Seq Age Sex Outcome Treatment
    1