BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRA AV

    MDR report key: 15803267 · Received November 16, 2022

    Report

    Report Number
    9612164-2022-04253
    Event Type
    Death
    Date Received
    November 16, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 16, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00763000078621
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: BRAND NAME: MICRA, MODEL #: MC1AVR1-DELSYS, EXPIRATION DATE: 2023-12-28, SERIAL#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEV RTN TO MFR? NO, MFG DATE: 2022-08-15, DEVICE LABELED FOR SINGLE USE: YES. 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

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE LEADLESS IPG DIFFICULT TO ADVANCE TO THE HEART, WHICH THE PHYSICIAN BELIEVED MAY HAVE BEEN DUE TO AN ISSUE INSIDE THE BODY, WITH EXTRA CUTS NEEDED AT THE GROIN SITE. THE GUIDEWIRE BEING USED WAS NOT A STIFF WIRE.  THE LEADLESS IPG WAS ULTIMATELY PLACED AFTER DIFFICULT PLACEMENT AND INABILITY TO RECAPTURE WITH ACCEPTABLE SENSING, IMPEDANCE AND THRESHOLD VALUES.  APPROXIMATELY FOUR HOURS POST SURGERY, THE PATIENT WENT INTO CARDIAC ARREST AND HAD BEEN HYPOTENSIVE FOR APPROXIMATELY ONE HOUR, AND  WAS PALE AND DIAPHORETIC. THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355498 MICRA AV LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1AVR1 00763000078621

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Death