BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIA VR

    MDR report key: 3990804 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01758
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 5, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). THERE ARE 10 NON-SUSTAINED TACHYCARDIA (NST), 5 LEAD FAILURE PREDICTORS (LFP) EVENTS OF <(><<)>200 MS V-V CYCLE RECORDED BETWEEN (B)(6) 2013 AND (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (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 THERE WERE NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES THAT APPEARED TO BE FROM AN EXTERNAL SOURCE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469739 CARDIA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D384VRG

    Patients

    Seq Age Sex Outcome Treatment
    1