BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

    MDR report key: 3153606 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01148
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ALL FOUR LEADS WERE CONNECTED TO THE DEVICE AND THERE WAS NO PACING OR SENSING, THERE WAS NO INDICATION OF VENTRICULAR SENSING MARKERS, MEASUREMENT OF THRESHOLD WAS NOT POSSIBLE, AND ALL LEADS HAD HIGH IMPEDANCE. ALL LEAD MEASUREMENTS WERE ACCEPTABLE THROUGH THE ANALYZER. THE LEADS WERE CLEANED AND REINSERTED INTO THE DEVICE WITH THE SAME RESULTS. THE DEVICE WAS REMOVED AND REPLACED AND ALL MEASUREMENTS WERE ACCEPTABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254247 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR