BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ICD

    MDR report key: 9905417 · Received March 31, 2020

    Report

    Report Number
    2182208-2020-00635
    Event Type
    Death
    Date Received
    March 31, 2020
    Date of Event
    October 26, 2019
    Report Date
    April 13, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE OVERALL BASELINE GENDER CHARACTERISTICS IS MALE; THE AGE OF THE PATIENTS WAS APPROXIMATELY 62 YEARS OLD. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL NUMBERS LISTED. POSSIBLE MODELS COULD INCLUDE: VIVA, PROTECTA, CONSULTA, CLARIA MRI QUAD, AMPLIA MRI QUAD. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. THE EXACT CAUSE AND DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT; AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER FOR PATIENT INFORMATION. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿EFFICACY OF A DEVICE-BASED CONTINUOUS OPTIMIZATION ALGORITHM FOR PATIENTS WITH CARDIAC RESYNCHRONIZATION THERAPY.¿ CIRCULATION JOURNAL. 2019;84(1):18-25. DOI: 10.1253/CIRCJ.CJ-19-0691. 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 CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES. THE ARTICLE REPORTS THERE WERE PATIENT DEATHS; HOWEVER, THERE WAS NO INDICATION THAT THE DEATHS WERE DEVICE RELATED. THE MEDICAL HISTORY OF THE PATIENTS INVOLVED INDICATE THAT THERE IS A GREATER PROPENSITY FOR PATIENT MORTALITY. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE STATUS /LOCATION OF THE DEVICE IS UNKNOWN. THE CAUSE OF DEATH HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOWUP WHICH INDICATED THAT THERE WERE NO ADVERSE EVENTS RELATED TO THIS MANUFACTURER'S PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369639 MEDTRONIC ICD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death IMPLANTABLE PACING LEAD