BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRA AV

    MDR report key: 15366136 · Received September 6, 2022

    Report

    Report Number
    9612164-2022-03305
    Event Type
    Death
    Date Received
    September 6, 2022
    Date of Event
    August 11, 2022
    Report Date
    September 6, 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
    MO, 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: 28-JUN-2023 / SERIAL#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, MFG DATE: 11-FEB-2022 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 A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT EXPERIENCED MORE FREQUENT PAUSES, HYPOTENSION, NARROW COMPLEX COMPLETE HEART BLOCK (CHB), BRADYCARDIA AND THEY EXPIRED. IT WAS ALSO REPORTED THAT WHILE ADVANCING THE INTRODUCER SHEATH THE PATIENT BEGAN TO EXPERIENCE MORE FREQUENT PAUSES, WITH BRADYCARDIA AND CHB. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WHEN ADVANCED TO THE RIGHT VENTRICLE WITH THE LEADLESS IPG DELIVERY SYSTEM (DS), EXHIBITED DIMINISHED R-WAVES, HIGH IMPEDANCE AND NO CAPTURE AT HIGH OUTPUT, AFTER REDEPLOYMENT AND SIMILAR PARAMETERS, THE PATIENT'S BECAME HYPOTENSIVE, AND HAD A NARROW COMPLEX CHB, WITH BRADYCARDIA. THE LEADLESS IPG WAS ONCE AGAIN REDEPLOYED WITH NO CAPTURE, AT THIS POINT THE PATIENT WENT INTO PULSELESS ELECTRICAL (PEA). PATIENT RESUSCITATION WITH CARDIOPULMONARY RESUSCITATION WAS UNSUCCESSFULLY ATTEMPTED FOR 30 MINUTES AND MEDICAL INTERVENTION WAS REQUIRED DURING THE COURSE OF THE PROCEDURE. THIS DEATH HAS BEEN REFERRED TO THE CORONER TO REVIEW THE CASE. NO FURTHER INFORMATION SURROUNDING THE CAUSE OF DEATH IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842191 MICRA AV LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1AVR1 00763000078621

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death