BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUSTOM CRANIAL MESH - 1 WEEK

    MDR report key: 1276826 · Received December 30, 2008

    Report

    Report Number
    2021898-2008-00273
    Event Type
    Death
    Date Received
    December 30, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 30, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    EZX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNABLE TO BE RETURNED TO THE MANUFACTURER, THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE IS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER CMC34027 SHOW NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008, A PT UNDERWENT IMPLANTATION SURGERY. APPROXIMATELY 20-30 MINUTES AFTER SURGERY THE PT HAD CEREBRAL EDEMA. UPDATE 12/2/08: FDA CONTACTED MEDTRONIC CORPORATE SENIOR VP OF REGULATORY THAT THE PT DIED ON THE FOLLOWING MONTH AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM CRANIAL MESH - 1 WEEK 79MEP EZX MEDTRONIC NEUROSURGERY NA CMC34027

    Patients

    Seq Age Sex Outcome Treatment
    1 Death