BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 6162634 · Received December 9, 2016

    Report

    Report Number
    9612164-2016-01267
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00643169529748
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT IT WAS NOTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT PACING/CAPTURING. DURING IMPLANT THE DEVICE WAS DEPLOYED AND TWO TINES WERE NOTED TO BE ENGAGED. THE TETHER REMOVAL PROVED TO BE SOMEWHAT CHALLENGING WITH NOTABLE PULLBACK ON THE DEVICE ASSOCIATED WITH TETHER REMOVAL. THERE WAS ALSO NOTED TO BE MOTION ON THE DEVICE ASSOCIATED WITH THE CARDIAC CYCLE. NUMBERS REMAINED SIMILAR WITH THOSE PRIOR TO TETHER REMOVAL, BUT WITH THE ONE NOTABLE EXCEPTION THAT THE R WAVES HAD DROPPED WHICH WAS NOT THOUGHT AT THE TIME TO BE A MAJOR COMPLICATING FACTOR. THRESHOLD WAS A BIT VARIABLE BUT WITHIN RANGE. THE NEXT MORNING AFTER IMPLANT HOWEVER, THE DEVICE WAS NOTED TO HAVE DISLODGED, WITH TOTAL LOSS OF CAPTURE. THE IPG WAS REMOVED VIA A GOOSENECK SNARE AND A NEW LEADLESS IPG WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810223 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01US 00643169529748

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R