BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 6160166 · Received December 9, 2016

    Report

    Report Number
    9612164-2016-01245
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: MC1VR01-DELSYS PRODUCT EVENT SUMMARY: THE DELIVERY SYSTEM WAS RETURNED AND ANALYZED. ANALYSIS INDICATED THE SHAFT WAS KINKED/BUCKLED AND BLOOD WAS VISIBLE IN THE SHAFT AND SHEATH. IT WAS NOTED THE CATHETER ARTICULATED, BUT THE SHAFT WAS KINKED AT 5CM (FROM DISTAL TIP). VISUAL SUMMARY OF ANALYSIS INDICATED DAMAGE DURING USE. (B)(4).

    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 DURING THE IMPLANT PROCEDURE FOR THE TRANSCATHETER PACING SYSTEM (TPS), A HIGH PACING THRESHOLD VALUE WAS OBSERVED WHEN THE PACEMAKER WAS PLACED IN THE MID-SEPTAL POSITION. THE PACEMAKER WAS RECAPTURED INTO THE DELIVERY SYSTEM AND 10-12 ATTEMPTS WERE MADE TO REPOSITION THE DEVICE, HOWEVER, ALL POSITIONS FROM THE HIGH-SEPTAL TO THE APEX RESULTED IN NO EFFECTIVE STIMULATION AT HIGH OUTPUTS. THE PHYSICIAN THEN NOTED THE DELIVERY SYSTEM BENT IN THE VENA CAVA AND WAS ABLE TO NAVIGATE BACK TO THE RIGHT ATRIUM AND RIGHT VENTRICLE, BUT THE PHYSICIAN WAS NOT ABLE TO KEEP THE PUSH TO THE DELIVERY SYSTEM WHEN TRYING TO DEPLOY THE DEVICE. THE DELIVERY SYSTEM SHOWED A 'GOOSENECK' AND THE PHYSICIAN COMMENTED THE TIP FELT SOFTER THAN BEFORE. THE TPS WAS THEN REMOVED FROM THE PATIENT AND AN ADDITIONAL CURVE IN THE DELIVERY SYSTEM WAS NOTED. THE TPS WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811357 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1