BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2222152 · Received August 24, 2011

    Report

    Report Number
    2649622-2011-13710
    Event Type
    Death
    Date Received
    August 24, 2011
    Date of Event
    July 26, 2011
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. 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 COMPANY REPRESENTATIVE THAT THE PATIENT DIED AT AN INITIAL IMPLANT. THE PHYSICIAN IMPLANTED A PACING LEAD AND THE PATIENT WENT INTO ASYSTOLE AND HEART BLOCK. THE LEAD WAS ADVANCED INTO THE VENTRICLE AND THE ANALYZER WAS USED TO PACE THE PATIENT. WHILE CONTINUING TO PACE A SECOND LEAD WAS PLACED IN THE VENTRICULAR APEX AND SECURED. THE LEAD VIA THE ANALYZER TESTED WITH IN NORMAL RANGE. HOWEVER, SHORTLY AFTER THE TESTING THE PATIENT'S BLOOD PRESSURE AND HEART RATE DROPPED AND THEN WENT INTO VENTRICULAR FIBRILLATION. CARDIO PULMONARY RESUSCITATION WAS STARTED AND A PERICARDIAL CENTESIS WAS PERFORMED. THE PATIENT WAS FOUND TO HAVE HEMOPERICARDIUM. DESPITE EFFORTS THE PATIENT DIED. A PERFORATION OF THE HEART IS SUSPECTED. THE LEADS REMAINED IN THE BODY.

    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 Death| H| L| R