BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIDA CRT-D

    MDR report key: 2964716 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00424
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 12, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    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. (B)(4). CONCOMITANT PRODUCT: 4296-88 IMPLANTABLE PACING LEAD 2012 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE THE IMPLANTATION OF THE DEFIBRILLATOR AND LEAD THE PATIENT DID NOT HAVE ANY FAST VENTRICULAR EVENTS. AFTER THE IMPLANTATION, IT WAS NOTED THE PATIENT HAD SEVERAL FAST VENTRICULAR TACHYCARDIA'S. THE SYSTEM WAS REMOVED AND REPLACED DUE TO THE SUSPICION OF THE ALGORITHMS BEING PRO-ARRHYTHMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66671 EGIDA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D394TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6935-65 IMPLANTABLE PACING LEAD