BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPF SPINE FUSION STIMULATOR

    MDR report key: 1628873 · Received March 11, 2010

    Report

    Report Number
    2242816-2010-00015
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Date of Event
    January 15, 2010
    Report Date
    February 17, 2010
    Manufacturer
    EBI, LLC
    Product Code
    LOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE LEADS WERE DISCONNECTED FROM THE STIMULATOR WHEN THE STIMULATOR CAME OUT OF THE BOX. THE DEVICE WAS REASSEMBLED, HOWEVER, IT WAS DECIDED TO NOT IMPLANT THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANTABLE STIMULATOR. PATIENT OUTCOME: NO ADVERSE AFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPF SPINE FUSION STIMULATOR SPF XL IIB MESH LOE EBI, LLC 214772

    Patients

    Seq Age Sex Outcome Treatment
    1