BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2021033 · Received March 16, 2011

    Report

    Report Number
    2647346-2011-00288
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    March 18, 2008
    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. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. LEAD MODEL 6949 IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT (16 CENTIMETERS IN LENGTH) WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. THERE WAS EVIDENCE OF TORN INNER INSULATION AND BREACHED/CUT OUTER INSULATION. ALL DISTAL CONDUCTORS WERE DISTORTED. APPARENT EXPLANT DAMAGE NOTED. EVALUATION SUMMARY (B)(4): THE PROXIMAL SEGMENT (14 CENTIMETERS IN LENGTH) WAS RETURNED AND ANALYZED (ONLY VISUAL ANALYSIS PERFORMED). PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. THERE WAS EVIDENCE OF TORN INNER INSULATION AND BREACHED/CUT OUTER INSULATION. INNER INSULATION WAS KINKED/BUCKED. APPARENT EXPLANT DAMAGE NOTED. ANALYSIS OF THE DEVICES (B)(4) AND (B)(4) IS 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. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. LEAD MODEL 6949 IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT (16 CENTIMETERS IN LENGTH) WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. THERE WAS EVIDENCE OF TORN INNER INSULATION AND BREACHED/CUT OUTER INSULATION. ALL DISTAL CONDUCTORS WERE DISTORTED. APPARENT EXPLANT DAMAGE NOTED. EVALUATION SUMMARY (B)(4): THE PROXIMAL SEGMENT (14 CENTIMETERS IN LENGTH) WAS RETURNED AND ANALYZED (ONLY VISUAL ANALYSIS PERFORMED). PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. THERE WAS EVIDENCE OF TORN INNER INSULATION AND BREACHED/CUT OUTER INSULATION. INNER INSULATION WAS KINKED/BUCKED. APPARENT EXPLANT DAMAGE NOTED. (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) DETAILED ANALYSIS OF THE DEVICE WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THAT PATIENT DIED APPROXIMATELY SIX MONTHS POST IMPLANT OF THE RIGHT VENTRICULAR LEAD. ADDITIONALLY IT WAS REPORTED THE PATIENT HAD EXPERIENCED EXTREME PHYSICAL INJURY. FURTHER REVIEW REVEALED THE PATIENT DIED SIX MONTHS POST IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY WITH DEFIBRILLATOR (CRT-D) SYSTEM.

    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 69 YR Death