BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 1246745 · Received November 25, 2008

    Report

    Report Number
    MW5009079
    Event Type
    Death
    Date Received
    November 25, 2008
    Report Date
    November 25, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    EZX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS RECENTLY UNDERWENT IMPLANTATION OF A MEDTRONIC CUSTOM TITANIUM CRANIOPLASTY IMPLANT -MEDTRONIC CATALOG NUMBER CMESH1WK- AT MEDICAL CENTER-, AND SUFFERED AN UNEXPECTED POST-OP COURSE. PATIENT 1 UNDERWENT IMPLANTATION IN 2008. APPROX 20-30 MINUTES AFTER IMPLANTATION, THE PT SEIZED; EVALUATION REVEALED ACUTE CEREBRAL EDEMA, WITH RESULTING SEVERE NEUROLOGIC COMPROMISE. THE PATIENT DIED AS A RESULT OF THIS INJURY THE FOLLOWING MONTH. DATES OF USE: #1: 2008. #2: 2008.

    Description of Event or Problem · 2

    TWO PATIENTS RECENTLY UNDERWENT IMPLANTATION OF A MEDTRONIC CUSTOM TITANIUM CRANIOPLASTY IMPLANT -MEDTRONIC CATALOG NUMBER CMESH1WK- AT MEDICAL CENTER-, AND SUFFERED AN UNEXPECTED POST-OP COURSE. PT UNDERWENT IMPLANTATION IN 2008. APPROX 45 MINUTES AFTER IMPLANTATION, THE PT SEIZED; EVALUATION REVEALED ACUTE CEREBRAL EDEMA, WITH RESULTING SEVERE NEUROLOGIC COMPROMISE. THE PT DIED AS A RESULT OF THIS INJURY FIVE DAYS LATER. THIS EVENT WAS REPORTED TO THE DEPARTMENT OF HEALTH -DATES OF USE: #1: 2008, #2: 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC CMESH CUSTOM TITANIUM CRANIOPLASTY IMPLANT EZX MEDTRONIC CMC35624
    2 MEDTRONIC CMESH CUSTOM TITANIUM CRANIOPLASTY IMPLANT EZX MEDTRONIC TV81543

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death
    2 49 YR Death