BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1915884 · Received December 6, 2010

    Report

    Report Number
    2647346-2010-00790
    Event Type
    Death
    Date Received
    December 6, 2010
    Date of Event
    January 22, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER TUBING OVERLAY COSMETIC ESC AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION MELTED AND COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC ESC AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER TUBING OVERLAY COSMETIC ESC AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION MELTED AND COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC ESC AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    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) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER TUBING OVERLAY COSMETIC ESC AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION MELTED AND COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC ESC AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY 3 MONTHS AFTER DEVICE IMPLANT. FOLLOW UP WITH THE CLINIC LATER REVEALED PATIENT HOSPITALIZED FOR ENDSTAGE CARDIOMYOPATHY APPROXIMATELY 3 WEEKS PRIOR TO DEATH AND THEN DISCHARGED TO HOME ON HOSPICE CARE WITH ICD THERAPIES TURNED OFF, PACING THERAPY REMAINED ON. THERE WERE NO CONCERNS WITH DEVICE OR LEAD PERFORMANCE. CAUSE OF DEATH REPORTED AS THE ENDSTAGE CARDIOMYOPATHY. NO AUTOPSY WAS DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY 3 MONTHS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR ASKU NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death