BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 17270765 · Received July 6, 2023

    Report

    Report Number
    9612164-2023-03039
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    April 1, 2023
    Report Date
    July 6, 2023
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 MALE/15 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. REFERENCED ARTICLE: TRANSCATHETER LEADLESS PACING IN CHILDREN: A PACES COLLABORATIVE STUDY IN THE REAL-WORLD SETTING. CIRCULATION: ARRHYTHMIA AND ELECTROPHYSIOLOGY. 2023;16:E011447. DOI: 10.1161/CIRCEP.122.011447. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING LEADLESS PACING IN CHILDREN. THE AUTHORS DESCRIBED PATIENTS WHO EXPERIENCED POSTOPERATIVE COMPLICATIONS AND COMPLICATIONS DURING USE. ONE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WITH TAMPONADE WHICH WAS EVACUATED BY PERICARDIOCENTESIS WITHOUT FURTHER SEQUELAE, AND THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS LEFT IN PLACE. THERE WAS ONE PATIENT WHERE THEY COULD NOT IMPLANT THE LEADLESS IPG DUE TO NO MYOCARDIAL CAPTURE. DEVICE DEPLOYMENT AND RETRIEVAL WERE PERFORMED NUMEROUS TIMESAFTER WHICH THE PROCEDURE WAS ABORTED WITH DEVICE RETRIEVAL AND REMOVAL. SOME PATIENTS EXPERIENCED BLEEDING FROM THE FEMORAL VENOUS ACCESS SITE AND RESOLVED WITH MANUAL COMPRESSION. ANOTHER PATIENT DEVELOPED A HEMATOMA AT FEMORAL VENOUS SITE THAT RESOLVED WITHOUTFURTHER INTERVENTION. DEVELOPMENT OF RIGHT BUNDLE BRANCH BLOCK ASSOCIATED WITH LEADLESS IPG IMPLANTATION AT A HIGH SEPTAL SITE WAS OBSERVED IN ONE PATIENT AND PERSISTED FOR ONE WEEK AND THEN SPONTANEOUSLY RESOLVED. ONE DEVICE EXHIBITED HIGH PACING THRESHOLDS DEVELOPED AND THE PATIENT EXPERIENCED DIAPHRAGMATIC PACING WHEN THE PACEMAKER WAS PROGRAMMED AT HIGH OUTPUT. THE PATIENT UNDERWENT RETRIEVAL OF THE DEVICE, AND A NEW DEVICE WAS IMPLANTED IN A MID-SEPTAL LOCATION. AN ADDITIONAL PATIENT DEVELOPED ATTENUATION OF MEASURED R-WAVES FOUR DAYS AFTER IMPLANT AND WAS TREATED WITH A FIVE-DAY COURSE OF ORAL STEROIDS WITH SUBSEQUENT IMPROVEMENT OF MEASURED R WAVES. THERE WERE OTHER PATIENTS WHO EXPERIENCED NEW ONSET OR WORSENING TRICUSPID REGURGITATION. THERE WAS A NONOCCLUSIVE THROMBUS IN THE RIGHT COMMON FEMORAL VEIN FOR WHICH ANTICOAGULATION WITH ENOXAPARIN WAS INITIATED FOR TWO MONTHS IN A PATIENT. FOLLOW-UP ULTRASOUND SIX WEEKS POST IMPLANT SHOWED RESOLVED THROMBUS AND VENOUS PATENCY. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031438 MICRA INTRODUCER, CATHETER DYB MEDTRONIC IRELAND MI2355A

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Required Intervention| H