BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 5455490 · Received February 23, 2016

    Report

    Report Number
    2182208-2016-00705
    Event Type
    Death
    Date Received
    February 23, 2016
    Date of Event
    January 1, 2016
    Report Date
    February 4, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P850051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). 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. THE PMA NUMBER FOR THIS REPORT LISTED IS PART OF A COMBINATION OF PMAS CONSIDERED THE "1-CARD" AND CONSISTS OF P820003, P850051, P890003, P930022, P970012 AND P980035. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: PREDICTION OF ALL-CAUSE MORTALITY BASED ON THE DIRECT MEASUREMENT OF INTRATHORACIC IMPEDANCE. CIRC. HEART FAIL. 2016;9(1):1941-3289. (B)(4)..

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND THE SUBSEQUENT FOLLOW UP INFORMATION OBTAINED. REFERENCED ARTICLE: PREDICTION OF ALL-CAUSE MORTALITY BASED ON THE DIRECT MEASUREMENT OF INTRATHORACIC IMPEDANCE. CIRC. HEART FAIL. 2016;9(1):1941-3289.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) OR CARDIAC RE-SYNC HRONIZATION DEVICE (CRT-D) SYSTEMS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE PATIENT DEATHS. THERE WERE NO DEVICE ALLEGATIONS NOTED. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. THE CAUSE OF DEATH AND DEVICE-RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH A CO-AUTHOR WHO INDICATED THAT THE DEATHS WERE NOT DEVICE-RELATED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111412 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Death