BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1912739 · Received December 2, 2010

    Report

    Report Number
    2649622-2010-12197
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    September 9, 2010
    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
    MS, 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED ON (B)(6)-2010, TWO DAYS AFTER REPLACEMENT OF A DEVICE AND LEAD. FOLLOW UP WITH CLINIC REPORTED "PATIENT WAS COMPLAINING OF VF/VTON ADMIT TO THE HOSPITAL" 8 DAYS PRIOR TO DEATH WITH 12 SHOCKS DELIVERED. UNKNOWN TO CLINIC NURSE IF SHOCKS APPROPRIATE OR NOT. PATIENT WAS NOT DEPENDENT. LAST CLINIC VISIT AND DEVICE CHECK WAS 3 DAYS BEFORE HOSPITAL ADMIT AND WAS NORMAL/UNREMARKABLE EXCEPT THE BATTERY WAS APPROACHING ERI (ELECTIVE REPLACEMENT INDICATOR). DEVICE WAS REPLACED AND WAS WORKING PROPERLY. DISCHARGE NOTES FROM HOSPITAL INDICATE ARRANGEMENTS WERE MADE FOR PALLIATIVE CARE. CAUSE OF DEATH WAS UNKNOWN TO THE CLINIC.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2010, TWO DAYS AFTER REPLACEMENT OF A DEVICE AND LEAD. FOLLOW UP WITH CLINIC REPORTED REPORTED "PATIENT WAS COMPLAINING OF VF/VT(VENTRICULAR FIBRILLATION/VENTRICULAR TACHYCARDIA) ON ADMIT TO THE HOSPITAL" 8 DAYS PRIOR TO DEATH WITH 12 SHOCKS DELIVERED. UNKNOWN TO CLINIC NURSE IF SHOCKS APPROPRIATE OR NOT. PATIENT WAS PACEMAKER DEPENDENT. LAST CLINIC VISIT AND DEVICE CHECK WAS 3 DAYS BEFORE HOSPITAL ADMIT AND WAS NORMAL/UNREMARKABLE EXCEPT THE BATTERY WAS APPROACHING ERI. DEVICE WAS REPLACED AND WAS WORKING PROPERLY. DISCHARGE NOTES FROM HOSPITAL INDICATE ARRANGEMENTS WERE MADE FOR PALLIATIVE CARE. CAUSE OF DEATH WAS UNKNOWN TO THE CLINIC. FOLLOW UP WITH PHYSICIAN'S OFFICE REPORTED ONLY "THAT THIS PATIENT WAS VERY SICK."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2010, TWO DAYS AFTER REPLACMENT OF A DEVICE AND LEAD. THE CAUSE OF DEATH HAS BEEN REQUESTED AND 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 65 YR Death| H| L| R