BEUDAMED
    FDA Adverse Event Other Summary report: N

    BELOS DR

    MDR report key: 682059 · Received March 2, 2006

    Report

    Report Number
    1028232-2006-00018
    Event Type
    Other
    Date Received
    March 2, 2006
    Date of Event
    November 23, 2005
    Report Date
    February 27, 2006
    Manufacturer
    BIOTRONIK, GMBH AND CO.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEVICE DEPLETION, CAUSE INITIALLY UNK. 108 CHARGES DUE TO SENSING ARTIFACTS. DURING THE EXPLANT, IT IS NOTED THAT NO EFH WAS USED TO FIXATE THE LEAD; MACROSCOPICALLY, THERE IS NO DAMAGE TO THE LEAD, BUT COLOR DIFFERENCES IN THE LIGATURE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELOS DR ICD LWS BIOTRONIK, GMBH AND CO. 338170 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention