BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2003380 · Received March 1, 2011

    Report

    Report Number
    2649622-2011-03113
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    February 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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, DEFIB CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING OVERLAY COSMETIC ESC AND BREACH/BREACH (NON-ELECTRICAL), OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC ESC AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC 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 LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY - (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A MONOMORPHIC VENTRICULAR TACHYCARDIA, ANTITACHYCARDIC PACING FAILED, RHYTHM ACCELERATED TO VF (VENTRICULAR FIBRILLATION), ONE SHOCK AT 25 JOULES AND 5 SHOCKS AT 35 JOULES ALL FAILED TO CONVERT VF, AND THE PATIENT DIED. FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REPORTED THE DEVICE AND LEADS HAD ALL BEEN WORKING NORMALLY AND ALL DEVICE TESTING POST DEATH SHOWS NORMAL FUNCTION. FURTHER REPORTED THE PATIENT'S HEART PHYSIOLOGICALLY SIMPLY COULD NOT RESPOND TO THE SHOCKS AS WAS VERY SICK PATIENT. THE DEVICE AND LEADS WERE LATER RETURNED FOR ANALYSIS WITH REPORT OF POTENTIAL PERFORMANCE ISSUE. THE CAUSE OF DEATH IS BEING REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A MONOMORPHIC VENTRICULAR TACHYCARDIA, ANTITACHYCARDIC PACING FAILED, RHYTHM ACCELERATED TO VF (VENTRICULAR FIBRILLATION), ONE SHOCK AT 25 JOULES AND 5 SHOCKS AT 35 JOULES ALL FAILED TO CONVERT VF, AND THE PATIENT DIED. FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REPORTED THE DEVICE AND LEADS HAD ALL BEEN WORKING NORMALLY AND ALL DEVICE TESTING POST DEATH SHOWS NORMAL FUNCTION. FURTHER REPORTED THE PATIENT'S HEART PHYSIOLOGICALLY SIMPLY COULD NOT RESPOND TO THE SHOCKS AS WAS VERY SICK PATIENT. THE DEVICE AND LEADS WERE LATER RETURNED FOR ANALYSIS WITH REPORT OF POTENTIAL PERFORMANCE ISSUE. THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A MONOMORPHIC VENTRICULAR TACHYCARDIA, ANTITACHYCARDIA PACING FAILED, RHYTHM ACCELERATED TO VF (VENTRICULAR FIBRILLATION), ONE SHOCK AT 25 JOULES AND 5 SHOCKS AT 35 JOULES ALL FAILED TO CONVERT VF, AND THE PATIENT DIED. FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REPORTED THE DEVICE AND LEADS HAD ALL BEEN WORKING NORMALLY AND ALL DEVICE TESTING POST DEATH SHOWS NORMAL FUNCTION. FURTHER REPORTED THE PATIENT'S HEART PHYSIOLOGICALLY SIMPLY COULD NOT RESPOND TO THE SHOCKS AS WAS VERY SICK PATIENT. THE DEVICE AND LEADS WERE LATER RETURNED FOR ANALYSIS WITH REPORT OF POTENTIAL PERFORMANCE ISSUE. THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    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 62 YR Death