BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELOX EX 45-BP

    MDR report key: 1163248 · Received September 12, 2008

    Report

    Report Number
    1028232-2008-01090
    Event Type
    Other
    Date Received
    September 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    K994240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS RETURNED WITHOUT OOS DOCUMENTATION FROM MEDTRONIC, INC. THERE IS NO RECORD OF THE REMOVAL OR REPLACEMENT OF THE LEAD. THE FOLLOWING PHYSICIAN'S OFFICE WOULD NOT RETURN MY CALLS. THIS LEAD WAS RETURNED FOR UNKNOWN CAUSES. THE DATE OF EXPLANT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELOX EX 45-BP PACER LEAD DTB BIOTRONIK GMBH AND CO. 330132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization