BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 4932934 · Received July 22, 2015

    Report

    Report Number
    2182208-2015-02240
    Event Type
    Death
    Date Received
    July 22, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 25, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 70 YEARS OLD. THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. POSSIBLE LEAD MODELS REFERENCED IN THE ARTICLE INCLUDE: 6930, 6931, 6932, 6942, 6944, 6945, 6947, 6948, AND 6949. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: A COMPARATIVE STUDY OF DEFIBRILLATOR LEADS AT A LARGE-VOLUME IMPLANTING HOSPITAL: RESULTS FROM THE PACEMAKER AND IMPLANTABLE DEFIBRILLATOR LEADS SURVIVAL STUDY ("PAIDLESS"). JOURNAL OF INVASIVE CARDIOLOGY 2015; 27(6): 292-300. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS RECEIVED WHICH CONTAINED INFORMATION REGARDING RIGHT VENTRICULAR (RV) LEADS. MULTIPLE PATIENTS AND MULTIPLE MODELS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE PATIENT DEATHS. ADDITIONALLY LEAD REMOVAL WAS REPORTED DUE TO INFECTION AND/OR LEAD FAILURE ATTRIBUTED TO FAILURE TO CAPTURE AND SENSE NORMAL PACING IMPEDANCE, ABNORMAL DEFIBRILLATION IMPEDANCE, INSULATION DEFECT, FRACTURE, EXTRACARDIAC STIMULATION, CARDIAC PERFORATION, TRICUSPID VALVE ENTRAPMENT, LEAD TIP FRACTURE AND/ OR DISLODGMENT. THE STATUS OF THE LEADS IS UNKNOWN. THE CAUSE OF DEATH AND LEAD MODEL/RELATEDNESS HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475583 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death| H| R