BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 20990634 · Received December 20, 2024

    Report

    Report Number
    9612164-2024-06140
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    August 19, 2024
    Report Date
    December 20, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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/58 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: IS DAY-CASE SURGICAL PROCEDURE SAFE FOR MICRA LEADLESS PACEMAKER IMPLANTATION? JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2024. DOI: 10.1007/S10840-024-01907-7 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 SAME-DAY (SD) DISCHARGE VERSUS OVERNIGHT (ON) OBSERVATION IN PATIENTS UNDERGOING LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTS. THE AUTHORS DESCRIBED ONE PATIENT IN THE SD GROUP WHO DEVELOPED PULMONARY SYMPTOMS AND WAS DIAGNOSED WITH A PULMONARY EMBOLISM TWO WEEKS POST PROCEDURE. THERE WERE THREE MILD GROIN BLEEDING OR HEMATOMA IN BOTH GROUPS. IN THE ON GROUP, THERE WAS ONE PATIENT WHO DEVELOPED AN ARTERIOVENOUS FISTULA WHICH REQUIRED SURGICAL INTERVENTION AND ONE PATIENT WITH A MILD GROIN INFECTION POST PROCEDURE. THERE WAS ALSO ONE FAILED IMPLANT IN THE ON GROUP; THE DEVICE DISLODGED SOON AFTER THE TETHER WAS CUT BUT WAS RETRIEVED AND THE IMPLANT WAS ABANDONED. 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
    2164884 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MDT-TPS-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other