BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 10100051 · Received May 29, 2020

    Report

    Report Number
    9612164-2020-02015
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 25, 2020
    Report Date
    July 2, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: D1: MICRA D4: MODEL #: MC1VR01-DELSYS D10: YES, RETURN DATE: 17-JUN-2020. H3: YES. DEV RTN TO MFR? YES. H6: FDA METHOD CODE(S): 10 H6: FDA RESULTS CODE(S): 180, 3243 H6: FDA CONCLUSION CODE(S): 4315 PRODUCT EVENT SUMMARY: THE FULL DELIVERY SYSTEM WAS RETURNED WITH THE DEVICE INTACT IN THE DEVICE CUP. THE LUMEN OF THE DELIVERY SYSTEM WAS TORN. THE ARTICULATION CURVE OF THE DELIVERY SYSTEM DID NOT MEET SPECIFICATION. THE ARTICULATION OF THE DELIVERY SYSTEM WAS OUT OF PLANE. THE DELIVERY SYSTEM OUTER SHAFT WAS KINKED/BUCKLED AT 5 CM FROM THE DISTAL END OF THE DELIVERY SYSTEM. BLOOD WAS OBSERVED ON THE DEVICE CUP OF THE DELIVERY SYSTEM. BLOOD WAS OBSERVED ON THE RECAPTURE CONE OF THE DELIVERY SYSTEM. THE ANALYST NOTED THE ARTICULATION TEST FAILED DUE TO THE ARTICULATION BEING OUT OF PLANE AND THE CURVE BEING OUT OF SPECIFICATION DUE TO THE OUTER SHAFT BEING KINKED. THE OPERATION OF THE BUTTONS (BOTH DEPLOYMENT AND ARTICULATION BUTTONS) WERE WITHIN NORMAL SPECIFICATION AND NOT LOOSE AT TIME OF ANALYSIS. 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

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. 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

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: MICRA, MODEL #: MC1VR01-DELSYS / EXPIRATION DATE: 28-MAY-2021 / SERIAL#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO,MFG DATE: 25-MAY-2020, LABELED FOR SINGLE USE: YES, (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT PROCEDURE THE IPG EXHIBITED PACING PROBLEMS AND HIGH IMPEDANCE, HIGH THRESHOLDS AND LOW SENSING. THE IPG WAS REPOSITIONED SIX TIMES BUT ACCEPTABLE MEASUREMENTS COULD NOT BE OBTAINED. THE IPG AND DELIVERY SYSTEM WERE REMOVED AND CLEANED. UPON REINSERTION, REPOSITIONING WAS ATTEMPTED AGAIN BUT WAS UNSUCCESSFUL. IT WAS NOTED THAT THE PHYSICIAN COULD NOT PLACE THE IPG SUCCESSFULLY AS THE DELIVERY SYSTEM WAS "VERY SOFT" AND DIFFICULT TO CONTROL. THE IPG AND DELIVERY SYSTEM WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT PROCEDURE THE IPG EXHIBITED PACING PROBLEMS AND HIGH IMPEDANCE, HIGH THRESHOLDS AND LOW SENSING. THE IPG WAS REPOSITIONED SIX TIMES BUT ACCEPTABLE MEASUREMENTS COULD NOT BE OBTAINED. IT WAS NOTED THAT THE PHYSICIAN COULD NOT PLACE THE IPG SUCCESSFULLY AS THE DELIVERY SYSTEM WAS "VERY SOFT". THE IPG AND DELIVERY SYSTEM WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564837 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR