BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA¿ AV2

    MDR report key: 19937028 · Received August 8, 2024

    Report

    Report Number
    9612164-2024-03618
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 17, 2024
    Report Date
    September 10, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00763000078645
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) THAT THE DEVICE HAD TO BE RECAPTURE DUE TO LOW WAVE AMPLITUDE SENSING. AFTER DEPLOYING THE DEVICE A SECOND TIME THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM (DS) TO RECAPTURE THE DEVICE. THE DS WAS THEN REMOVED FROM THE BODY AND INSPECTED. IT WAS NOTED THAT THE DS HAD TROUBLE FLUSHING AS IT WAS MET WITH A LOT OF RESISTANCE. THE DEVICE WAS RE-INSERTED AND ATTEMPTED TO DEPLOY A THIRD TIME, THE TINES ENGAGED, HOWEVER, THE PHYSICIAN COULD NOT PULL THE DS BACK. THE LEADLESS IPG AND DS WERE ATTEMPTED/NOT USED 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
    2397726 MICRA¿ AV2 LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC2AVR1 00763000078645

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female