BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR AT

    MDR report key: 1926441 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02318
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL EPISODE, WAS TAKEN TO THE EMERGENCY ROOM, CARDIOPULMONARY RESUSCITATION WAS USED AND THE ELECTROCARDIOGRAM SHOWED VENTRICULAR TACHYCARDIA. IT WAS ALSO REPORTED THAT THE DEVICE SHOWED A VENTRICULAR FIBRILLATION EPISODE AND SEVERAL NON-SUSTAINED VENTRICULAR TACHYCARDIAS. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. C174AWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R