BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1981978 · Received February 8, 2011

    Report

    Report Number
    2649622-2011-00203
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    October 15, 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
    VT, US
    Reporter Occupation
    RISK MANAGER

    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, PROXIMAL CONDUCTOR STRETCHED, BLOOD/BODY FLUID (NOT OBSTRUCTED), INNER INSULATION TORN, OUTER INSULATION COSMETIC AND BREACHED CUT, LEAD STRETCHED, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND.

    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, PROXIMAL CONDUCTOR STRETCHED, BLOOD/BODY FLUID (NOT OBSTRUCTED), INNER INSULATION TORN, OUTER INSULATION COSMETIC AND BREACHED CUT, LEAD STRETCHED, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED APPROXIMATELY 7 MONTHS FOLLOWING DEVICE IMPLANT. THE CAUSE OF DEATH IS BEING REQUESTED.

    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 84 YR Death LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD