BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 7094669 · Received December 7, 2017

    Report

    Report Number
    9612164-2017-01814
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    October 24, 2017
    Report Date
    April 10, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00643169529748
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID# MC1VR01US. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. CONTINUATION OF FDC: 71 FDR: 213 FDM: 10, 23, 26, 38. PRODUCT ID# MC1VR01-DELSYS PRODUCT EVENT SUMMARY: THE FULL DELIVERY SYSTEM WAS RETURNED. ANALYSIS WAS PERFORMED AND FOUND THAT THE SHAFT WAS MECHANICALLY KINKED/BUCKLED. THE SHAFT OF THE DELIVERY SYSTEM WAS MECHANICALLY BENT. THE ANALYSIS NOTED THAT THE DEVICE WAS RECEIVED WITH THE DELIVERY SYSTEM. VISUAL INSPECTION FOUND THAT THE DELIVERY SYSTEM TIP WAS DAMAGED/ BENT. THE SHAFT WAS KINKED AT DISTANCE 5.5 CM, MEASURED FROM THE DISTAL TIP. ALTHOUGH THE DELIVERY SYSTEM DISTAL TIP WAS DAMAGED, BUT THE DEPLOYMENT AND CURVATURE TEST RESULTS WERE PASSED. THE DELIVERY SYSTEM WAS FAILED BECAUSE THERE WAS FOUND FLAT WIRE EXPOSED FROM SHAFT AT DISTANCE 3.5 CM. /MEASURED FROM THE DISTAL TIP. FDC: 77 FDR: 114, 3038 FDM: 10, 23, 38. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: MC1VR01-DELSYS. 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 IPG DID NOT FULLY DEPLOY FROM THE DELIVERY SYSTEM AND ONLY ONE TINE APPEARED TO BE ENGAGED. ATTEMPTS WERE MADE TO RECAPTURE THE IPG BUT IT COULD NOT BE COMPLETELY RECAPTURED. EVENTUALLY, THE DELIVERY CATHETER AND DEVICE WERE PULLED INTO THE OUTER INTRODUCER SHEATH AND WERE REMOVED FROM THE BODY. EVALUATION OF THE DELIVERY SYSTEM INDICATED A SMALL INDENTATION OF AT THE DISTAL END WHICH PREVENTED RECAPTURE. THE IPG WAS NOT IMPLANTED AND ANOTHER IPG WAS USED. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870269 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01US 00643169529748

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR