BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1902377 · Received November 18, 2010

    Report

    Report Number
    2649622-2010-12089
    Event Type
    Death
    Date Received
    November 18, 2010
    Date of Event
    March 3, 2008
    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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), INNER INSULATION KINKED/BUCKLED, OUTER INSULATION BREACHED CUT AND COSMETIC DEPRESSION, BLOOD IN/ON HELIX/LOBE MECHANISM, LEAD STRETCHED, APPARENT EXPLANT DAMAGE. FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), INNER INSULATION KINKED/BUCKLED, OUTER INSULATION BREACHED CUT AND COSMETIC DEPRESSION, BLOOD IN/ON HELIX/LOBE MECHANISM, LEAD STRETCHED, APPARENT EXPLANT DAMAGE. FULL LEAD RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS BY THE MEDICAL EXAMINER THAT THE PATIENT DIED WITH CAUSE OF DEATH UNKNOWN. IT WAS CONFIRMED THERE WERE NO DEVICE PERFORMANCE ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS BY THE MEDICAL EXAMINER THAT THE PATIENT DIED. IT WAS CONFIRMED THERE WERE NO DEVICE PERFORMANCE ISSUES. FOLLOW UP LATER DETERMINED THE DATE OF DEATH WAS (B)(6) 2008 AND THE CAUSE OF DEATH WAS NATURAL - HYPERTENSION AND ATHEROSCLEROTIC CARDIOVASCULAR DISEASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death