BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 6162959 · Received December 9, 2016

    Report

    Report Number
    9612164-2016-01272
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 12, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOON AFTER IMPLANT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) THE PATIENT EXPERIENCED TWO VENTRICULAR TA CHYCARDIA (VT) EPISODES WHICH HAD TO BE DEFIBRILLATED. AT THIS TIME THE PATIENT HAD AN EJECTION FRACTION (EF) OF 43%. THE PATIENT THEN HAD AN EPISODE OF PERSISTENT VT. THE PHYSICIAN ATTEMPTED TO ABLATE THE TACHYCARDIA WITH NO SUCCESS. PATIENT¿S EF WAS NOW 15%. DURING ABLATION THEY MEASURED THE POINT OF FIRST POLARIZATION WHICH WAS VERY CLOSE TO THE IPG. THE IPG WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811260 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R