BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 16386802 · Received February 16, 2023

    Report

    Report Number
    9612164-2023-00706
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    April 28, 2022
    Report Date
    February 16, 2023
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THIS STUDY CAPTURED 7,821 PATIENTS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/75 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 WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: CLINICAL OUTCOMES AND PREDICTORS OF COMPLICATIONS IN PATIENTS UNDERGOING LEADLESS PACEMAKER IMPLANTATION. HEART RHYTHM 2022; 19:1289¿1296. DOI: 10.1016/J.HRTHM.2022.03.1226. PMID: 35490710. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE ARTICLE REPORTS PATIENT DEATHS DURING THE INDEX HOSPITALIZATION AND POST PROCEDURE FOR THE LEADLESS IPG IMPLANTATION. THERE WAS ONE PATIENT DEATH RELATED TO THE IMPLANT PROCEDURE, HOWEVER, THE CAUSE OF DEATH WAS UNKNOWN. ALL OTHER PATIENT DEATHS WERE LABELED AS "ALL-CAUSE" WITH NO SPECIFIC CAUSES OF DEATH KNOWN. PATIENTS EXPERIENCED ADVERSE EVENTS SUCH AS ACUTE VENOUS THROMBOEMBOLISM, ACUTE STROKE, BLEEDING EVENTS WHICH REQUIRED BLOOD TRANSFUSIONS, INFECTIONS, PROCEDURE-RELATED VASCULAR COMPLICATIONS, PERICARDIAL EFFUSION WITH AND WITHOUT PERICARDIOCENTESIS, THORACOTOMY AMONG PATIENTS WITH EFFUSION, DEVICE DISLODGMENT WHICH REQUIRED REMOVAL OR REPOSITIONING OF THE LEADLESS IPG. THE STATUS/DISPOSITION OF THE DEVICES IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557671 MICRA INTRODUCER, CATHETER DYB MEDTRONIC IRELAND MI2355A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Life Threatening| R