BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2813573 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06599
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    November 8, 2012
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    Z-0111-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD WORSENING HEART FAILURE AND SEPTICEMIA. IT WAS NOTED THAT THE PATIENT WAS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO THE PATIENT HAVING ENDOCARDITIS. A TEMPORARY PACING SYSTEM IS BEING USED UNTIL A NEW SYSTEM CAN BE IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD DEVELOPED A FEVER AND MALAISE. IT WAS NOTED THAT THE DEVICE HAD POSSIBLE EROSION. CULTURES WERE TAKEN AND ANTIBIOTIC THERAPY WAS STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 1488TC (X2) COMPETITOR IMPLANTABLE PACING LEADS