BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1924202 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06106
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    August 23, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO PATIENT ANATOMY THE SET SCREW EXPERIENCED TORQUE AND BECAME LOOSE. THE LEAD THAN HAD INCREASED IMPEDANCE AND THE PATIENT ALERT WAS TRIGGERED. THE SET SCREW WAS TIGHTENED AND LEAD WAS PULLED FROM THE HEADER AND HAD ADEQUATE THRESHOLDS AND PACING. THE LEAD AND DEVICE ARE STILL IN USE. 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 MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD