BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1992241 · Received February 15, 2011

    Report

    Report Number
    2647346-2011-00183
    Event Type
    Death
    Date Received
    February 15, 2011
    Date of Event
    October 31, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WERE OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS WAS PERFORMED. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS WAS PERFORMED. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WERE OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ANALYSIS OF THE LEADS ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WERE OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WERE OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS WAS PERFORMED ONLY.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY TEN MONTHS FROM SYSTEM IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY TEN MONTHS FROM SYSTEM IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED, THE PATIENT WENT INTO HOSPICE CARE AND DEVICE THERAPIES WERE TURNED OFF APPROXIMATELY THREE MONTHS PRIOR TO DEATH. THE PATIENT WAS NOT PACEMAKER DEPENDANT. THE CAUSE OF DEATH IS COMPLICATIONS OF HUMAN IMMUNODEFICIENCY VIRUS. THERE ARE NO ALLEGATIONS FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE AND/OR LEAD RELATED.

    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 68 YR Death