BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1924570 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02273
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 5, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE SET SCREW WAS LODGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO PACING CAPTURE IN THE RIGHT VENTRICLE. DURING A REVISION PROCEDURE IT WAS NOTICED THAT THE SET SCREW WAS STUCK IN THE DEVICE CONNECTOR BLOCK AND IT WAS NOT POSSIBLE TO CONNECT THE LEAD TO THE DEVICE. A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D234TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6948 IMPLANTABLE TACHY LEAD