BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA AV

    MDR report key: 12459764 · Received September 13, 2021

    Report

    Report Number
    9612164-2021-03503
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    August 21, 2021
    Report Date
    September 29, 2021
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DRUG LOT NUMBER: R141941 C4: TREATMENT/THERAPY FROM DATE: (B)(6) 2021.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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FOUR WEEKS POST IMPLANT, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF GENERALIZED WEAKNESS AND MALAISE AND WAS FOUND TO BE IN COMPLETE HEART BLOCK WITH A HEART RATE IN THE FORTIES. IT WAS ALSO REPORTED THAT THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) WHERE ON FURTHER EVALUATION IT WAS NOTED THAT THE DEVICE DID NOT MODE SWITCH APPROPRIATELY TO FACILITATE ATRIOVENTRICULAR CONDUCTION. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN ACCELEROMETER SENSING FOR MICRA AV ((B)(6)  CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357214 MICRA AV LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1AVR1 00763000078621

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R