BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ICD

    MDR report key: 20422270 · Received October 10, 2024

    Report

    Report Number
    2182208-2024-04392
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    January 30, 2024
    Report Date
    October 10, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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/62 YEARS OLD. 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: DEVICE INFECTION IN PATIENTS UNDERGOING PACEMAKER OR DEFIBRILLATOR SURGERY: RISK STRATIFICATION USING THE PADIT SCORE. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2024. 67: 1419¿1426. DOI: 10.1007/S10840-024-01759-1. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING DEVICE INFECTION IN PATIENTS UNDERGOING CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) PROCED URES. THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE SPECIFIC CAUSES OF DEATH WERE UNKNOWN. THE DEATHS WERE CATEGORIZED AS CARDIOVASCULAR OR NON-CARDIOVASCULAR DEATHS. NONE OF THE PATIENTS THAT DIED HAD A HOSPITALIZATION FOR CIED INFECTION. 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. THERE WERE PATIENTS WHO EXPERIENCED A POCKET INFECTION OR SYSTEMIC INFECTION WITHIN ONE YEAR OF FOLLOW-UP. MOST CASES OCCURRED WITHIN THE FIRST FIVE WEEKS AFTER THE PROCEDURE. PATHOGENS WERE STAPHYLOCOCCUS AUREUS, STAPHYLOCOCCUS EPIDERMIDIS, KLEBSIELLA VARIICOLA, COAGULASE-NEGATIVE STAPHYLOCOCCI, OR ENTEROCOCCUS FAECALIS. PATIENTS WERE HOSPITALIZED AND TREATED WITH ANTIBIOTICS AND/OR HAD A CIED SYSTEM REMOVAL OR REVISION. THE STATUS OF THE DEVICES AND LEADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293882 MEDTRONIC ICD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R UNKNOWN COMPETITOR LEADS.