BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2024350 · Received March 18, 2011

    Report

    Report Number
    2649622-2011-04119
    Event Type
    Death
    Date Received
    March 18, 2011
    Date of Event
    May 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. ALL INFORMATION KNOWN WAS PROVIDED AND NO FURTHER INFORMATION IS AVAILABLE. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE.

    Description of Event or Problem · 1

    REVIEW OF MANUFACTURER'S DATABASE INDICATED THAT THE PATIENT DIED APPROXIMATELY THREE MONTHS FOLLOWING IMPLANT OF DEFIBRILLATOR AND RIGHT VENTRICULAR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death