BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1813552 · Received August 25, 2010

    Report

    Report Number
    2649622-2010-08906
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    July 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PROXIMAL SEGMENT RETURNED AND ANALYZED. ALL CONDUCTORS DISTORTED, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED). 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 AND LEADS 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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. ALL CONDUCTORS DISTORTED, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED). PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) THE DEVICE DID NOT MEET EXPECTED LONGEVITY. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED WITH CAUSE OF DEATH NOTED TO BE SEPSIS FOR ONE WEEK AND CARDIAC ARREST. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED WITH CAUSE OF DEATH NOTED TO BE SEPSIS FOR ONE WEEK AND CARDIAC ARREST. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP WITH CLINIC REPORTED THE PATIENT WAS "A VERY SICK GUY." LAST CLINIC VISIT HAD BEEN (B)(6)2010, PATIENT IN CHRONIC ATRIAL FIBRILLATION, BATTERY VOLTAGE 2.65V, AND OPTIVOL TRIGGERED (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death