BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2250326 · Received September 15, 2011

    Report

    Report Number
    2647346-2011-01197
    Event Type
    Death
    Date Received
    September 15, 2011
    Date of Event
    January 31, 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
    MN, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED) THERE WAS APPARENT EXPLANT DAMAGE AND VISUAL ANALYSIS ONLY 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, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED) THERE WAS APPARENT EXPLANT DAMAGE AND VISUAL ANALYSIS ONLY WAS PERFORMED. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND VISUAL ANALYSIS ONLY WAS PERFORMED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY FIVE MONTHS AFTER DEVICE SYSTEM IMPLANTED. 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) COMPETITOR IMPLANTABLE PACING LEAD