BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR

    MDR report key: 221427 · Received April 28, 1999

    Report

    Report Number
    2242816-1999-00019
    Event Type
    Malfunction
    Date Received
    April 28, 1999
    Date of Event
    April 9, 1999
    Report Date
    April 15, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    LOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 4 MONTHS POST IMPLANTATION, THE PT COMPLAINED OF NUMBNESS AND TINGLING DOWN HER LEFT ARM INTO HER FINGERTIPS. IT WAS NOTED ON X-RAY THAT THE CATHODE WAS BROKEN. THE STIMULATOR WAS EXPLANTED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR Implant IMPLANTABLE BONE GROWTH STIMULATOR LOE ELECTRO-BIOLOGY, INC. 10-1325 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other