BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM DR

    MDR report key: 407112 · Received July 10, 2002

    Report

    Report Number
    2182208-2002-00326
    Event Type
    Injury
    Date Received
    July 10, 2002
    Date of Event
    April 23, 2002
    Manufacturer
    MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LONG CHARGE TIME REPORTED ON ICD. SENSING DIFFICULTY/OVERSENSING AND FRACTURE REPORTED ON V LEAD. FRACTURE REPORTED ON A LEAD; IT SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION 7271 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other