BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR-T

    MDR report key: 2190125 · Received June 30, 2011

    Report

    Report Number
    1028232-2011-01457
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOTRONIK SE & CO KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER REPOSITIONING BOTH LEADS ON (B)(6) 2011, THIS DEVICE COULD NOT BE INTERROGATED AND COULD NOT BE RE-INITIALIZED. THE PHYSICIAN REPLACED THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS DR-T PACEMAKER DTB BIOTRONIK SE & CO KG 349806

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization