BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIA VR

    MDR report key: 3864765 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01497
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Additional Manufacturer Narrative · 1

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

    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 WAS PERFORMED WITH NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED FOR RIGHT VENTRICULAR (RV) LEAD FAILURE. THE RV LEAD WAS FOUND TO HAVE HIGH UNSTABLE IMPEDANCE WITH OVERSENSING AND SEVERAL SHORT INTERVAL COUNTS (SIC). THERE IS A CONCERN THAT THE RV LEAD MAY NOT BE FULLY INSERTED INTO THE CONNECTION HEADER OF THE ICD. THE ICD AND RV LEAD 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
    337798 CARDIA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D384VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR 6947-65 LEAD