BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC CRT-D

    MDR report key: 14111833 · Received April 14, 2022

    Report

    Report Number
    2182208-2022-01180
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    March 30, 2021
    Report Date
    April 14, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/(B)(6). THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: PATIENTS WITH HEART FAILURE AND AN IMPLANTED CARDIOVERTER-DEFIBRILLATOR DURING THE CORONAVIRUS DISEASE 2019 PANDEMIC: INSIGHTS FROM A MULTICENTER REGISTRY IN POLAND. KARDIOLOGIA POLSKA. 2021; 79(5): 562¿565. DOI: 10.33963/KP.15918. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING PATIENTS WITH HEART FAILURE AND AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) OR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DURING THE CORONAVIRUS DISEASE 2019 PANDEMIC. THE ARTICLE REPORTS PATIENTS WHO EXPERIENCED INAPPROPRIATE THERAPY FROM THEIR DEVICES OR LEADS WITH UNKNOWN CAUSES AND PATIENT HOSPITALIZATIONS. THERE WERE ALSO ICD AND CRTD DYSFUNCTIONS, BUT THE TYPES OF DYSFUNCTIONS ARE NOT KNOWN. THE STATUS/DISPOSITION OF THE DEVICES AND LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190743 MEDTRONIC CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC, INC. MDT-CRT-D

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Life Threatening| H UNKNOWN COMPETITOR LEADS