BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1902802 · Received November 18, 2010

    Report

    Report Number
    2649622-2010-12104
    Event Type
    Death
    Date Received
    November 18, 2010
    Date of Event
    May 4, 2009
    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
    NJ, 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.

    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; THE FULL LEAD WAS RETURNED FOR ANALYSIS. THE DEFIB CONDUCTOR WAS DISTORTED AND THE OUTER INSULATION WAS BREACHED/CUT. BLOOD WAS OBSERVED IN/ON HELIX MECHANISM. THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) NO ANOMALIES FOUND AND THE BATTERY DEPLETION WAS NORMAL. (B)(4) NO ANOMALIES FOUND; THE FULL LEAD WAS RETURNED FOR ANALYSIS. THE DEFIB CONDUCTOR WAS DISTORTED AND THE OUTER INSULATION HAD COSMETIC DEPRESSIONS. BLOOD WAS OBSERVED IN/ON HELIX MECHANISM. THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED LESS THAN 5 MONTHS AFTER DEVICE WAS IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 88 YR Death