BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 15092675 · Received July 25, 2022

    Report

    Report Number
    9612164-2022-02799
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    June 30, 2022
    Report Date
    August 31, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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), AFTER THE LEADLESS IPG DELIVERY SYSTEM (DS) TETHER WAS CUT, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE, CARDIAC PERFORATION, RESULTANT CARDIAC TAMPONADE, CONFIRMED ON ECHOCARDIOGRAM AND CARDIAC ARREST, WITH RESUSCITATION FOR 10 MINUTES. INITIALLY, THERE WAS DIFFICULTY IN INSERTING THE DILATOR INTO THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SHEATH, THEREFORE, THE INTRODUCER SHEATH WAS ATTEMPTED/NOT USED AND REPLACED WITH A LARGER SIZED SHEATH. POST FIRST IMPLANT ATTEMPT, THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DISLODGED DURING THE PULL AND HOLD TEST. BEFORE THE FIRST SUCCESSFUL IMPLANT, A COMPUTERIZED TOMOGRAPHY (CT) CONFIRMED THAT THE LEADLESS IPG AND ITS DS WERE NEAR THE LOWER CARDIAC WALL, AND IT WAS DEEMED POSSIBLE THAT THE HEART WAS PERFORATED AT THIS TIME, POSSIBLY RELATING TO POSITIONING/PLACEMENT. IT WAS IMMEDIATELY AFTER THE FIRST SUCCESSFUL IMPLANTATION AND CUTTING THE LEADLESS IPG DS TETHER, THAT THE PATIENT BECAME UNSTABLE. AFTER THE PATIENT'S CONDITION STABILIZED, POST CARDIAC ARREST, A THORACOTOMY WAS PERFORMED. IT WAS DISCOVERED THAT DURINGTHE THORACOTOMY THAT THE LEADLESS IPG DAMAGED TINE AT 9 O'CLOCK, HAD POTENTIALLY PERFORATED THE HEART, WHERE THE METAL PART ON THE FREE WALL SIDE WAS VISIBLE AFTER THORACOTOMY. HEMORRHAGING WAS VISUALIZED, BUT IT COULD NOT BE CONFIRMED WITH OTHER DEVICES, SO THE PROCEDURE WAS COMPLETED. POST TREATMENT, THE PATIENT'S CONDITION STABILIZED. THE LEADLESS IPG REMAINS IN USE. MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116859 MICRA INTRODUCER, CATHETER DYB MEDTRONIC IRELAND MI2355A 00166179

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Life Threatening| R| H