BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 13259356 · Received January 14, 2022

    Report

    Report Number
    2182208-2022-00136
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    October 18, 2021
    Report Date
    March 1, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: BRAND NAME: MICRA, MODEL #: MC1VR01-DELSYS, EXPIRATION DATE: UNKNOWN, SERIAL#: UNKNOWN, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEV RTN TO MFR? NO. MFG DATE: UNKNOWN. LABELED FOR SINGLE USE: YES. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: INSUFFICIENT PROCEDURAL ANTICOAGULATION DURING LEADLESS PACING LED TO CATHETER-RELATED THROMBOSIS IN A HEMODIALYSIS PATIENT. BMC CARDIOVASCULAR DISORDERS. 2021. 21:502 DOI.ORG/10.1186/S12872-021-02318-6. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: D4:MODEL #: MC1VR01-DELSYS CORRECTION: H6: D15. 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

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT. THE ARTICLE REPORTS THAT DURING THE IMPLANT OF THE LEADLESS IPG, DUE TO UNFAVORABLE ELECTRICAL MEASUREMENTS, THE DEVICE REQUIRED REPOSITIONING. DURING THE REPOSITIONING, THE DELIVERY CUP COULD NOT BE ADVANCED DUE TO GREAT RESISTANCE, AND THE IPG WAS NOT ABLE TO BE WITHDRAWN INTO THE CATHETER. THE WHOLE DELIVERY CATHETER HAD TO BE REMOVED FROM THE DELIVERY SHEATH. IT WAS NOTED THAT THE LUMEN WAS FULLY FILLED WITH HEAVY THROMBI DUE TO INSUFFICIENT ANTICOAGULANT THERAPY. ADDITIONAL ANTICOAGULANTS WERE ADMINISTERED IMMEDIATELY. AFTER THE THROMBI WAS REMOVED, THE MOBILITY OF THE DELIVERY CATHETER RECOVERED AND THE DEVICE WAS ABLE TO BE REMOVED. TO PREVENT A THROMBOEMBOLISM, A NEW PACEMAKER SYSTEM WAS IMPLANTED. THE STATUS/DISPOSITION OF THE DEVICE APPEARS TO BE STILL 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
    730291 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC, INC. MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male