BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUREFIX

    MDR report key: 2160403 · Received July 13, 2011

    Report

    Report Number
    2649622-2011-10839
    Event Type
    Death
    Date Received
    July 13, 2011
    Date of Event
    January 23, 2011
    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
    TN, 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.

    Description of Event or Problem · 1

    IT WAS FOUND BY AN EMPLOYEE SEARCH OF THE REGISTRATION DATABASE THAT THE PATIENT WAS DECEASED. FOLLOW UP REVEALED THE PATIENT HAD A HISTORY OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION THAT WAS PERSISTANT AND HAD EXHAUSTED THE BATTERY OF A PREVIOUS DEVICE DUE TO MULTIPLE APPROPRIATE SHOCKS WHICH RESULTED IN THE PATIENT NEEDING EXTERNAL DEFIBRILLATION WHICH WAS OFTEN TIMES UNSUCCESSFUL, PER THE PHYSICIAN. FURTHER FOLLOW UP REVEALED THE CAUSE OF DEATH TO BE LISTED AS CARDIAC ARREST. NO COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE AGAINST THE DEVICE SYSTEM OR ANY OF THE INDIVIDUAL COMPONENTS.

    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 51 YR Death| O