BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 6214741 · Received December 29, 2016

    Report

    Report Number
    2182208-2016-02939
    Event Type
    Death
    Date Received
    December 29, 2016
    Date of Event
    December 24, 2015
    Report Date
    December 2, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P900061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE REFERENCED IN THE ARTICLE, BUT WITH NO DEVICE/PRODUCT FAILURE CORRELATION/SERIAL NUMBERS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS APPROXIMATELY (B)(6) YEARS OLD. POSSIBLE MODELS COULD INCLUDE MAXIMO II, EN TRUST, SECURA, VIRTUOSO, CONCERTO, CONCERTO II, CONSULTA, PROTECTA, AND PROTECTA XT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: FONTENLA A, MARTINEZ-FERRER JB, ALZUETA J, ET AL. INCIDENCE OF ARRHYTHMIAS IN A LARGE COHORT OF PATIENTS WITH CURRENT IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS IN SPAIN: RESULTS FROM THE UMBRELLA REGISTRY. EUROPACE. 2016;18(11):1726-1734. 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 DEVICE MODELS 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 FROM UNKNOWN CAUSES AND PATIENTS WHO EXPERIENCED INAPPROPRIATE THERAPIES INCLUDING ELECTRICAL STORMS. THE STATUS OF THE DEVICE IS UNKNOWN. THERE IS NO ALLEGATION OF DEVICE-DEATH RELATEDNESS INDICATED IN THE ARTICLE; HOWEVER, THE CAUSE OF DEATH AND DEVICE-RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863574 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| L| R