BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2022643 · Received March 17, 2011

    Report

    Report Number
    2649622-2011-04102
    Event Type
    Death
    Date Received
    March 17, 2011
    Date of Event
    November 9, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S FAMILY THAT THE PATIENT DIED ONE WEEK AFTER UPGRADE FROM AN IMPLANTABLE CARDIAC DEFIBRILLATOR TO A BI-VENTRICULAR DEFIBRILLATOR. THE PATIENTS FAMILY REPORTED THAT THE PATIENT "HAD DEFECTIVE DEVICES IN HIM THAT KILLED HIM" AND "WHY WAS THE FIRST ICD REPLACED AFTER ONLY ONE YEAR? YOUR DEVICES WERE FAULTY." THE PATIENT'S FAMILY ALSO REPORTED "DEFIBRILLATOR CAUSED MY HUSBANDS DEATH.". THE CAUSE OF DEATH HAS BEEN REQUESTED, BUT NOT RECEIVED.

    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 68 YR Death