BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUREFIX

    MDR report key: 1813601 · Received August 25, 2010

    Report

    Report Number
    2649622-2010-08885
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    January 20, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S4
    Removal / Correction Number
    ASKU
    Adverse Event
    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 THERE WAS OCCASIONAL ATRIAL ARTIFACT AND CAPTURE FAILURE. IT WAS LATER REPORTED A TEE DEMONSTRATED ATRIAL THROMBUS. REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THE PATIENT REPORTEDLY EXPIRED DUE TO AORTIC STENOSIS. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED THE PATIENT HAD BEEN SEEN IN CLINIC (B)(6)2009 AND THERE WERE NO DEVICE ISSUES. RETURNED TO CLINIC (B)(6)2009 TO HAVE ALERTS, TACHYCARDIA DETECTION AND THERAPY TURNED OFF PRIOR TO MOVING TO HOSPICE. BRADYCARDIC PACING REMAINED ON AS PATIENT WAS PACEMAKER DEPENDENT WITH COMPLETE HEART BLOCK. CAUSE OF DEATH WAS REPORTED TO BE CONGESTIVE HEART FAILURE AND RENAL FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OCCASSIONAL ATRIAL ARTIFACT AND CAPTURE FAILURE. IT WAS LATER REPORTED A TEE DEMONSTRATED ATRIAL THROMBUS. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THE PATIENT REPORTEDLY EXPIRED DUE TO AORTIC STENOSIS. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5072 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death