BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM VR

    MDR report key: 1071969 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00315
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    September 26, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 OF THE DEVICE REVEALED THAT A CAPACITOR WAS OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7227CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6936 IMPLANTABLE TACHY LEAD