BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE EPI

    MDR report key: 1813567 · Received August 25, 2010

    Report

    Report Number
    2649622-2010-08903
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    April 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 DAYS FOLLOWING IMPLANT OF PACEMAKER, THE PATIENT'S HEART RATE INCREASED AND THEN DECREASED TO 30 BEATS PER MINUTE BEFORE GOING INTO ASYSTOLE. THE PATIENT WAS RESUSITATED, WAS VERY UNSTABLE, AND DIED A FEW DAYS LATER DUE TO EDEMA OF THE BRAIN. PRINTOUTS FROM THE PACEMAKER "FROM THE DAY WHERE THE SYNCOPE HAPPENED" NOTED ATRIAL FIBRILLATION INITIATING VENTRICULAR FIBRILLATION. TESTING OF THE DEVICE SHOWED EVERYTHING WAS NORMAL AND THERE WAS NO INDICATION OF DEVICE MALFUNCTION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death