BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION-1X8

    MDR report key: 1853889 · Received September 7, 2010

    Report

    Report Number
    3007566237-2010-06844
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF DEVICE MODEL 37081 (B)(4), REVEALED THAT ONE CORNER OF THE INNER LID HAD LOOSENED FROM THE INNER TRAY ALLOWING THE CONNECTOR OF THE EXTENSION TO PROTRUDE BETWEEN THEM. THE STERILE SEAL OF THE OUTER TRAY WAS STILL INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE TIME OF AN IMPLANT PROCEDURE, THE PHYSICIAN HAD FOUND THAT THE EDGE OF THE "OCTAD ADAPTA" (EXTENSION) WAS PROTRUDING FROM THE PLASTIC LID. THE INNER SEAL OF THE PACKAGING WAS INTACT, HOWEVER, THE PHYSICIAN DECIDED TO PROCEED WITH ANOTHER DEVICE OF THE SAME MODEL. THE DEVICE, IN REGARDS TO THE PACKAGING ISSUE, HAD NOT BEEN IMPLANTED IN A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION-1X8 LGW MEDTRONIC NEUROMODULATION 37081

    Patients

    Seq Age Sex Outcome Treatment
    1