BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1697517 · Received May 25, 2010

    Report

    Report Number
    2649622-2010-05112
    Event Type
    Death
    Date Received
    May 25, 2010
    Date of Event
    January 21, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    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 SEGMENT RETURNED AND ANALYZED. (B) (4) BATTERY DEPLETION-NORMAL.

    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 SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS PACEMAKER DEPENDENT AND HAD LAST BEEN SEEN IN THE CLINIC (B) (6) 2008 WHEN THE BATTERY VOLTAGE WAS NOTED TO BE 2.5V. ON (B) (6) 2009, SHE FELL DOWN THE STAIRS IN HER HOME AND WAS TAKEN TO THE HOSPITAL WHERE SHE DIED THAT SAME DAY. THE PHYSICIAN REPORTED HER CAUSE OF DEATH TO BE BLUNT FORCE INJURY OF HEAD AND FALL. PHYSICIAN ALSO REPORTED "THERE WAS NO MECHANISM INDICATING THAT THE DEVICE WAS IMPLICATED IN ANY WAY AS CAUSING THE FALL OR DEATH, BUT WITHOUT INTERROGATION THEY WOULDN'T KNOW FOR SURE. PATIENT ALSO HAD A SIGNIFICANT HEART HISTORY, HER AGE, COUMADIN TX, ALL FACTORS THAT COULD HAVE CONTRIBUTED TO HER FALL."

    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 71 YR Death