BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM VR

    MDR report key: 2131760 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01263
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S47
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SHOCKED THREE TIMES DUE TO OVERSENSING, AND THAT THERE WAS HIGH IMPEDANCE GREATER THAN 2000 OHMS. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR) AND THAT IT THEN STOPPED SENSING. DURING THE EXPLANT PROCEDURE, THE HEADER BECAME SEPARATED. THE LEAD WAS CAPPED AND THE DEVICE AND LEAD WERE NOT REPLACED DUE TO IMPROVED EJECTION FRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7227B ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE TACHY LEAD