BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 53

    MDR report key: 739452 · Received July 21, 2006

    Report

    Report Number
    1028232-2006-00145
    Event Type
    Malfunction
    Date Received
    July 21, 2006
    Date of Event
    May 19, 2005
    Report Date
    August 22, 2005
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    p950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON 07/13/2006, STUDY ENROLLMENT FORM RECEIVED FROM CLINICAL STATING HIGH THRESHOLDS ON VENTRICULAR LEAD, LEAD REVISED. OOS RECEIVED 07/13/2006 WITH EXPLANT DATE AND REPLACEMENT LEAD INFORMATION DATED 2005. REVIEW OF CLINICAL STUDIES SHOWED THAT THIS DID NOT HAVE AN MDR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 53 BRADYCARDIA LEAD DTB BIOTRONIK GMBH AND CO 346 366 *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization