BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM III VR

    MDR report key: 1072590 · Received July 10, 2008

    Report

    Report Number
    6000094-2008-00331
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    January 10, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. EVALUATION SUMMARY: ANALYSIS CONFIRMED HIGH LEAD IMPEDANCE AND NO PACING OUTPUT. THIS WAS DUE TO A DEFORMED NANOCONNECTOR PIN THAT WAS PART OF THE VENTRICULAR SENSE PATHWAY. CONTACT RESISTANCE WAS INCREASED BETWEEN THE PIN AND SOCKET DUE TO THE DEFORMATION IN THE BIFURCATED PIN STRUCTURE. THE REDUCED CONTACT FORCE MADE THE CONNECTION SUSCEPTIBLE TO BOTH MOVEMENT AND OXIDE FORMATION OVER TIME ON THE PIN/SOCKET SURFACES. THIS RESULTED IN THE OBSERVED LOSS OF OUTPUT AND HIGH LEAD IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM III VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7231CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6947 IMPLANTABLE TACHY LEAD