BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 2051215 · Received April 12, 2011

    Report

    Report Number
    6000094-2011-00486
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 1, 2011
    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
    JA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS "ABNORMAL RIGHT VENTRICULAR (RV) IMPEDANCE." A REVISION PROCEDURE WAS DONE, AND THE RV LEAD COULD BE PULLED OUT OF THE CONNECTOR WITHOUT LOOSENING THE SETSCREW. THERE APPEARED TO BE "INSUFFICIENT INSERTION DUE TO AN OBSTRUCTION BY THE SETSCREW." THE LEAD WAS MEASURED MULTIPLE TIMES, RESULTING IN NORMAL MEASUREMENTS. THE LEAD WAS RE-CONNECTED TO THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE 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 86 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD