BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 6924233 · Received October 6, 2017

    Report

    Report Number
    9612164-2017-01408
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    July 20, 2017
    Report Date
    December 7, 2017
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: MC1VR01-DELSYS.

    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. FDC: 71 FDR: 213 FDM: 10, 23, 26, 38. PRODUCT ID MC1VR01-DELSYS. PRODUCT EVENT SUMMARY: THE FULL DELIVERY SYSTEM WAS RETURNED, ANALYZED. ANALYSIS INDICATED THAT THE SHAFT WAS MECHANICALLY KINKED/BUCKLED. BLOOD WAS OBSERVED ON THE SHAFT OF THE DELIVERY SYSTEM. VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE DURING USE. THE ANALYST NOTED THAT THE DELIVERY SYSTEM WAS RETURNED WITH THE DEVICE SEATED INSIDE THE DEVICE CUP, AND DRIED BLOOD VISIBLE ON THE DEVICE SITE AND ON THE DELIVERY SYSTEM. VISUAL INSPECTION FOUND THE SHAFT WAS KINKED AND TORN AT DISTANCE 99.5CM, MEASURED FROM THE HANDLE. FDC: 67 FDR: 114, 3038 FDM: 10, 26, 38. 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 PATIENT EXPERIENCED A PERFORATION WITH CARDIAC TAMPONADE. THE PATIENT UNDERWENT CARDIOPULMONARY RESUSCITATION, PERICARDIOCENTESIS AND A STERNOTOMY. IT WAS FURTHER THAT THE IPG HAD BEEN DEPLOYED SEVERAL TIMES, THE TINES WERE ENGAGED AND VERIFIED WITH THE TUG TEST; HOWEVER, THE THRESHOLDS AND SENSING WERE NOT WITHIN NORMAL LIMITS. THE DELIVERY SYSTEM AND IPG WERE REMOVED AND ANOTHER IPG WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701811 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01US 00643169529748

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R