BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2120551 · Received June 10, 2011

    Report

    Report Number
    2649622-2011-07790
    Event Type
    Death
    Date Received
    June 10, 2011
    Date of Event
    April 11, 2011
    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
    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE OUTER INSULATION WAS BREACHED AND HAD ENVIRONMENTAL STRESS CRACKING. THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED) AND ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS KINKED/BUCKLED AND BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD) AND IN/ON THE HELIX/LOBE MECHANISM. (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL AND PROXIMAL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT AND HAD A COSMETIC DEPRESSION, HAD A WHITE SUBSTANCE, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD) AND THE HELIX/LOBE MECHANISM, THERE WAS APPARENT EXPLANT DAMAGE AND THERE WAS A NON-ELECTRICAL MISCELLANEOUS FINDING ON THE SLEEVE HEAD INDICATING THAT THE LEAD WAS RETURNED WITH THE GUIDE TOOTH DAMAGED.

    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.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A COMPETITOR WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY TWO WEEKS AFTER DEVICE SYSTEM EXPLANTED. ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE SYSTEM WAS REMOVED DUE TO INFECTION. THE CAUSE OF DEATH IS CONGESTIVE HEART FAILURE, INFECTED MITRAL VALVE AND INFECTIVE ENDOCARDITIS. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH FEVER, CHILLS, FATIGUE AND TO RULE OUT ENDOCARDITIS. AN ECHOCARDIOGRAM REVEALED PARTIAL DEHISCENCE AND LARGE HIGHLY MOBILE VEGETATION ON THE MITRAL VALVE. BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS. WHILE WAITING FOR ENDOCARDITIS TO CLEAR, THE PATIENT DEVELOPED RESPIRATORY DISTRESS, PULMONARY EDEMA AND WAS ON RESPIRATORY SUPPORT. THE PATIENT ASPIRATED, WAS INTUBATED AND A CODE WAS CALLED. THE FAMILY REQUESTED INTERVENTION BE STOPPED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A COMPETITOR WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY TWO WEEKS AFTER DEVICE SYSTEM EXPLANTED. ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE SYSTEM WAS REMOVED DUE TO INFECTION. THE CAUSE OF DEATH IS CONGESTIVE HEART FAILURE, INFECTED MITRAL VALVE AND INFECTIVE ENDOCARDITIS.

    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 57 YR Death| H| L| R