BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1915891 · Received December 6, 2010

    Report

    Report Number
    2649622-2010-12252
    Event Type
    Death
    Date Received
    December 6, 2010
    Date of Event
    June 13, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASKU

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION NOTED THE PATIENT DIED APPROXIMATELY THREE MONTHS POST IMPLANT OF THE DEVICE SYSTEM. NO FURTHER INFORMATION IS CURRENTLY KNOWN. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    INFORMATION NOTED THE PATIENT DIED APPROXIMATELY THREE MONTHS POST IMPLANT OF THE TACHYCARDIA DEVICE. FOLLOW UP WITH CLINIC REPORTED PATIENT SEEN BY THEM APPROXIMATELY 2.5 MONTHS PRIOR TO DEATH AND PATIENT REPORTED FEELING BETTER SINCE AV(ATRIOVENTRICULAR) NODE ABLATION AND DEVICE IMPLANT. PATIENT WAS IN HOSPITAL THREE DAYS BEFORE DEATH FOR CONGESTIVE HEART FAILURE CONSULT. NOTES INDICATE PHYSICIAN REPORTED "PATIENT CONTINUES SMOKING 1/2 PACK PER DAY, HAD CLASS IV HEART FAILURE AND HIS PROGNOSIS WAS POOR." PATIENT'S CAUSE OF DEATH REPORTED AS CARDIAC ARREST. THERE IS NO ALLEGATION BY THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    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