BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 4049426 · Received August 29, 2014

    Report

    Report Number
    2021898-2014-00350
    Event Type
    Death
    Date Received
    August 29, 2014
    Date of Event
    March 1, 2013
    Report Date
    July 30, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN SAID THAT THE INFECTION HAD NOTHING TO DO WITH THE PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WAS IMPLANTED WITH THE ADJUSTABLE PRESSURE VALVE DUE TO HYDROCEPHALUS IN (B)(6) 2011. ACCORDING TO THE REPORT, THE PATIENT HAD AN INTRACRANIAL INFECTION THAT RESULTED IN A PULMONARY INFECTION. THE REPORT STATED THAT THE PATIENT DIED DUE TO PULMONARY INFECTION IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528216 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Death