BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1791113 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03126
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    March 24, 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
    TX, 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 3 WEEKS POST IMPLANT, THE DEVICE AND LEADS WERE EXPLANTED DUE TO INFECTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PATIENT WAS TREATED WITH AN ANTI-BIOTIC AND REPORTED AS FINE.

    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 78 YR Required Intervention