BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA AV

    MDR report key: 14190975 · Received April 23, 2022

    Report

    Report Number
    9612164-2022-01550
    Event Type
    Injury
    Date Received
    April 23, 2022
    Date of Event
    March 31, 2022
    Report Date
    June 1, 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
    DC, 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: 14-JUNE-2023, SERIAL#:(B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEV RTN TO MFR? NO, MFG DATE: 28-JAN-2022, LABELED FOR SINGLE USE?: YES. 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.

    Additional Manufacturer Narrative · 0

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: D9: YES, RETURN DATE: 05-MAY-2022. H3: YES. DEV RTN TO MFR?:YES. PRODUCT EVENT SUMMARY: A PARTIAL DELIVERY SYSTEM WAS RETURNED AND ANALYZED. THE ANALYSIS INDICATED THAT THE LUMEN OF THE DELIVERY SYSTEM WAS TORN. THE DELIVERY SYSTEM TETHER WAS BROKEN/CUT/PULLED APART. THE DELIVERY SYSTEM TETHER WAS FRAYED. BLOOD WAS OBSERVED IN THE LUMEN OF THE DELIVERY SYSTEM. BLOOD WAS OBSERVED ON THE RECAPTURE CONE OF THE DELIVERY SYSTEM. THE ANALYST NOTED A PARTIAL DELIVERY SYSTEM WAS RETURNED WITHOUT THE DEVICE, THE DELIVERY SYSTEM WAS RETURNED PARTIALLY INSERTED IN THE INTRODUCER THAT WAS RETURNED. A 20 ML SYRINGE WAS RETURNED WITH THE DELIVERY SYSTEM. THE DEPLOYMENT BUTTON WAS LOCKED IN THE DEPLOYED POSITION UPON RECEIPT. ARTICULATION COULD NOT BE TESTED AS ONLY A PARTIAL DELIVERY SYSTEM WAS RETURNED. DEPLOYMENT COULD NOT BE TESTED AS ONLY A PARTIAL DELIVERY SYSTEM WAS RETURNED. 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 IMPLANTATION OF LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) THE PHYSICIAN NOTICED THAT AFTER THE TETHER OF THE DELIVERY SYSTEM (DS) WAS CUT, RESISTANCE WAS FELT WHILE PULLING THE TETHER. THE DS WAS OBSERVED PULLING TOWARD THE DEVICE AND STEADY FORCE WAS BEING APPLIED.  DURING THE TETHER PULL, THE IPG DISLODGED AND WAS QUICKLY PULLED INTO THE RIGHT ATRIUM BY THE PHYSICIAN. THE TETHER WAS STILL ENGAGED WITH THE DEVICE AND THE PHYSICIAN ATTEMPTED TO PULL THE MICRA BACK INTO THE DELIVERY SYSTEM. THE DS AND IPG WAS CAUGHT UP AT THE VENONOMY AND HAD TO BE MANUALLY REMOVED USING SURGICAL INSTRUMENTS. A CONVENTIONAL TRANSVENOUS PACING SYSTEM WAS IMPLANTED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199862 MICRA AV LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1AVR1 00763000078621

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R