BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ICD

    MDR report key: 9496286 · Received December 19, 2019

    Report

    Report Number
    2182208-2019-02339
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    January 1, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US AND ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE, AND A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/57 YEARS OLD. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THE PMA NUMBER FOR THIS REPORT IS P900061. REFERENCED ARTICLE: SYSTEMATIC REVIEW AND META-ANALYSIS OF CLINICAL OUTCOME AFTER IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR THERAPY IN PATIENTS WITH CHAGAS HEART DISEASE JACC: CLINICAL ELECTROPHYSIOLOGY. 2019; 5(10):1213-1223 10.1016/J.JACEP.2019.07.003. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). THE AUTHORS OBTAINED INFORMATION FROM THREE HUNDRED NINETY-SEVEN ARTICLES AND THIRTEEN OBSERVATIONAL STUDIES. THE ARTICLE FOCUSED ON OUTCOMES SPECIFIC TO PATIENTS WITH CHAGAS HEART DISEASE AND REVEALED THERE WERE RATES OF ALL CAUSE MORTALITY AND INAPPROPRIATE SHOCKS. THE STATUS/DISPOSITION OF THE DEVICES IS NOT KNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292457 MEDTRONIC ICD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening