BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 1560131 · Received December 4, 2009

    Report

    Report Number
    1028232-2009-01650
    Event Type
    Malfunction
    Date Received
    December 4, 2009
    Date of Event
    October 14, 2009
    Report Date
    November 5, 2009
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITH A MEDTRONIC OOS FORM FROM MEDTRONIC, INC. THE FOLLOWING PHYSICIAN'S OFFICE HAS NO RECORD OF THIS PT. MEDTRONIC, INC HAS NO FURTHER INFO REGARDING THIS PT. PER THE VA MEDICAL CENTER, THIS SYSTEM WAS REMOVED DUE TO "A LEAD MALFUNCTION". THERE IS NO INFO AVAILABLE AS TO SPECIFICS OF THE MALFUNCTION. THIS DEVICE WAS REPLACED WITH A MEDTRONIC 5076, (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 60 PACER LEAD DTB BIOTRONIK SE & CO. KG 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization