BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 6211848 · Received December 28, 2016

    Report

    Report Number
    2182208-2016-02934
    Event Type
    Death
    Date Received
    December 28, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P900061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 DEVICE SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS APPROXIMATELY 12 YEARS OLD. WITHOUT THE SPECIFIC MODEL NUMBER(S), IT IS NOT POSSIBLE TO ASSURE THE SPECIFIC PRODUCT CORRECTION NUMBER REFERENCED IN THE ARTICLE IS LISTED IN THIS REPORT. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT, AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. 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: MIDTERM RESULTS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS IN CHILDREN AND YOUNG ADULTS FROM A SINGLE CENTER IN (B)(6). PACE PACING CLIN ELECTROPHYSIOL. 2016;39(11):1225-1239. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTED THAT THERE WERE PATIENT DEATHS AND PATIENTS WHO EXPERIENCED INAPPROPRIATE THERAPIES, POCKET INFECTIONS, LEAD INFECTIONS AND ACUTE BACTERIAL ENDOCARDITIS. THE ARTICLE REPORTED THAT SOME PATIENT RECEIVED NEW SYSTEMS. THE ARTICLE ADDITIONALLY REPORTED COMPLICATIONS THROUGHOUT THE STUDY INCLUDING LEAD CONNECTION PROBLEMS, DECREASED DEFIBRILLATION IMPEDANCE, LEAD FRACTURE AND LEAD DISLODGEMENT. THE STATUS OF THE ICDS AND LEADS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859122 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Death| H| L| R IMPLANTABLE TACHY LEAD