BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1813606 · Received August 25, 2010

    Report

    Report Number
    2649622-2010-08875
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    March 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS PACING THE VENTRICLE, THAT THE ATRIAL RATE WAS UNDETERMINED DUE TO LEAD SENSING AND THAT AN EGM SHOWED UNDETERMINED RHYTHM DUE TO ATRIAL LEAD OUT OF POSITION. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVELED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED, PATIENT WAS PACEMAKER DEPENDENT BECAUSE OF AN ABLATION DUE TO ATRIAL FIBRILLATION. DEVICE CHECK (B)(6)2008 SHOWED NORMAL PACING, SENSING AND IMPEDANCE. PRESENTED TO ER (B)(6)2008 WITH PNEUMONIA SECONDARY TO ASPIRATION ALONG WITH VOMITING AND DIARRHEA. PLACED ON VENTILATOR DUE TO RESPIRATORY FAILURE. IN HOSPITAL DEVICE CHECK ON (B)(6)2008 SHOWED NORMAL SENSING AND IMPEDANCE. PATIENT DIED DUE TO RESPIRATORY FAILURE ON (B)(6)2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS PACING THE VENTRICLE, THAT THE ATRIAL RATE WAS UNDETERMINED DUE TO LEAD SENSING AND THAT AN EGM SHOWED UNDETERMINED RHYTHM DUE TO ATRIAL LEAD OUT OF POSITION. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| R (B)(4) IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD