BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 12927190 · Received December 3, 2021

    Report

    Report Number
    2182208-2021-04743
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    January 1, 2019
    Report Date
    December 3, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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. 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 FEMALE/AGE IS UNKNOWN. 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 WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: A RISK SCORE MODEL FOR PREDICTING INTRAPROCEDURAL CARDIAC INJURY DURING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTATION: INSIGHTS FROM THE NATIONAL CARDIOVASCULAR DATA REGISTRY. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2019. 30:212-220. DOI: 10.1111/JCE.13823. 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 INTRAPROCEDURAL CARDIAC INJURY DURING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTATION. THE ARTICLE REPORTS PATIENTS WHO EXPERIENCED CARDIAC PERFORATIONS DURING THE IMPLANT. SOME PATIENTS EXPERIENCED CARDIAC TAMPONADE OR REQUIRED INTERVENTION. THE STATUS/DISPOSITION OF THE LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827380 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| R UNKNOWN ICD