BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 11147142 · Received January 11, 2021

    Report

    Report Number
    9612164-2021-00115
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 22, 2020
    Report Date
    January 11, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: MICRA-DELSYS D4: MODEL #: MC1VR01US-DELSYS / EXPIRATION DATE: 22-DEC-2020 / SERIAL#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO. EVALUATED BY MFR: NO. DEV RTN TO MFR? NO. MFG DATE: 14-JAN-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 IMPLANT PROCEDURE OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) THE TETHER OF THE DELIVERY SYSTEM (DS) BECAME TWISTED. AFTER MULTIPLE ATTEMPTS THE TETHER WAS UNTWISTED AND THE IMPLANT PROCEDURE PROGRESSED AFTER PLACING THE IPG AND DURING TETHER REMOVAL THE TETHER BECAME TIGHT AND DIFFICULT TO MOVE AFTER INITIALLY MOVING SMOOTHLY. THE TENSION SUBSEQUENTLY DISLODGED THE DEVICE. WHILE ATTEMPTING TO CAPTURE THE DEVICE THE TETHER "FULLY LET GO" AND THE DEVICE DISPLACED AND LODGED INTO ONE OF THE PULMONARY ARTERIES. THE DEVICE WAS ULTIMATELY RETRIEVED WITH A SHEATH AND SNARE. THE IPG AND DS WERE ATTEMPTED / NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45908 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR