BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1931074 · Received December 17, 2010

    Report

    Report Number
    2647346-2010-00937
    Event Type
    Death
    Date Received
    December 17, 2010
    Date of Event
    November 17, 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
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. (B)(4): A RESISTANCE INCREASE IS SEEN ON EACH LEAD BETWEEN (B)(6) 2010 AND (B)(6) 2010: FOR THE RV PACE LEAD IMPEDANCE, FROM 672 TO 824 OHMS; FOR THE LV PACE LEAD IMPEDANCE, FROM 592 TO 992 OHMS; FOR THE A PACE LEAD IMPEDANCE, FROM 496 TO 1048 OHMS, FOR THE DEFIB AND SVC DEFIB IMPEDANCES, 45 TO 60 OHMS, AND 56 TO 102 OHMS. OUT OF TOLERANCE LEAD IMPEDANCE ALERT IS RECORDED ON (B)(6) 2010 AT 02:15:05 FOR THE SVC LEAD IMPEDANCE AT 102 OHMS. THE HIGH ALERT SETTING IS 100 OHMS FOR THIS LEAD. 17 V-SIC WERE RECORDED BEGINNING (B)(6) 2010. THE LIFETIME COUNTER HAD ZERO COUNTS PRIOR TO THIS TIME. INCREASED SIC CAN INDICATE NOISE IN THE SYSTEM. TWO SHORT V-V SENSED EVENTS OF < 220 MS ARE OBSERVED ON THE (B)(6) 2010. (2 EPISODES NST). (B)(4): NO ANOMALIES FOUND, ALL CONDUCTORS STRETCHED, OUTER INSULATION COSMETIC DEPRESSION, LEAD STRETCHED, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, OUTER INSULATION COSMETIC ESC. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, INNER INSULATION PULLED APART (OVERSTRESS), INNER TUBING TORN, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. 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, ALL CONDUCTORS STRETCHED, OUTER INSULATION COSMETIC DEPRESSION, LEAD STRETCHED, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, OUTER INSULATION COSMETIC ESC. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, INNER INSULATION PULLED APART (OVERSTRESS), INNER TUBING TORN, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE NURSE WAS UNABLE TO GET HOLD OF THE PATIENT, THE POLICE CHECKED AND FOUND THE PATIENT DECEASED AT HOME. THE NURSE WAS QUESTIONING WHAT WOULD CAUSE THE IMPEDANCE TO RISE ON EVERY LEAD. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FOUND BY POLICE DECEASED AT HOME. THE NURSE WAS QUESTIONING WHAT WOULD CAUSE THE IMPEDANCE TO RISE ON EVERY LEAD. FOLLOW UP REVEALED PATIENT HAD LAST BEEN SEEN A MONTH PRIOR TO DEATH WITH A FULL DEVICE INTERROGATION. THERE WERE NO PROBLEMS WITH DEVICE AND IMPEDANCES ON THE LEADS WERE NORMAL. THEY DO NOT HAVE THE OFFICIAL CAUSE OF DEATH, BUT REPORT PATIENT WAS VERY SICK AND ATTRIBUTE THE DEATH TO MIXED ISCHEMIC AND NO-ISCHEMIC CARDIOMYOPATHY. PATIENT HAD EJECTION FRACTION OF 25 - 30% AND RENAL PROBLEMS.

    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 87 YR Death