BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 6783577 · Received August 9, 2017

    Report

    Report Number
    9612164-2017-01072
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    December 4, 2016
    Report Date
    June 26, 2017
    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

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: COMPLICATIONS WITH THE MICRA TPS PACEMAKER SYSTEM: PERSISTENT COMPLETE HEART BLOCK AND LATE CAPTURE FAILURE. PACE - PACING AND CLINICAL ELECTROPHYSIOLOGY. 2017; 40(4):455-456.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THE IMPLANT PROCEDURE FOR A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE ARTICLE REPORTS THAT DURING THE IMPLANTATION, THE PATIENT DEVELOPED PERSISTENT COMPLETE HEART BLOCK WITHOUT VENTRICULAR ESCAPE RHYTHM DUE TO MANIPULATION WITH THE DELIVERY CATHETER. TWO WEEKS POST IMPLANT, THE PATIENT WAS REFERRED TO THE HOSPITAL IN CARDIOGENIC SHOCK DUE TO BRADYCARDIA/ASYSTOLE. THERE WAS AN INCREASE OF PACING OUTPUT AND IMPEDANCE AS WELL AS FAILURE TO CAPTURE. THE PATIENT RECEIVED AN ADDITIONAL DUAL CHAMBER PACEMAKER SYSTEM. SIX WEEKS LATER, THE LEADLESS IPG HAD STABLE PACING THRESHOLDS. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. THE DEVICE STATUS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563788 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R MC1VR01-DELSYS