BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1991939 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00962
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE EMERGENCY ROOM AFTER RECEIVING SHOCKS PRECEDED BY DIZZINESS, AND MOMENTARILY PASSING OUT. UPON COMING THROUGH, AFTER RECEIVING THE SHOCKS, THE PATIENT WAS NOTED TO BE IN NORMAL SINUS RHYTHM (NSR), WITH LEFT BUNDLE BRANCH BLOCK (LBBB) AND NO BI-VENTRICULAR PACING. IT WAS ALSO NOTED THAT THE PATIENT HAD NO P-WAVES. DEVICE INTERROGATION REVEALED A VENTRICULAR FIBRILLATION EPISODE, AND UPON RECEIVING A SHOCK, ATRIAL SENSING HAD BEEN IMMEDIATELY LOST. IN ADDITION, THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE, AND THE PHYSICIAN WAS SUSPICIOUS OF DEVICE HEADER MALFUNCTION. SEVERAL DAYS LATER, THE RIGHT VENTRICULAR LEAD APPEARED TO HAVE DISLODGED. THE DEVICE, RIGHT VENTRICULAR, AND LEFT VENTRICULAR LEADS WERE EXPLANTED, AND IT WAS NOTED THAT THE IMPLANT POCKET APPEARED TO BE INFECTED. DAYS LATER, A NEW DEVICE AND LEADS WERE IMPLANTED. 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 II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R (B)(4) COMPETITOR IMPLANTABLE PACING LEAD