BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK STRATA VALVE/SHUNT

    MDR report key: 3144593 · Received May 31, 2013

    Report

    Report Number
    2021898-2013-00193
    Event Type
    Death
    Date Received
    May 31, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT CAME FROM THE LITERATURE ARTICLE TITLED "PROGRAMMABLE VALVE REPRESENTS AN EFFICIENT AND SAFE TOOL IN THE TREATMENT OF IDIOPATHIC NORMAL-PRESSURE HYDROCEPHALUS PATIENTS" FROM ARQUIVOS DE NEURO-PSIGUIATRIA VOL 71 NO 4 P 229-236 (2013). THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR REVEALED THAT THE VALVE WAS IMPLANTED SOMETIME BETWEEN 2010 AND 2012, AND THAT THE OMPLICATION OCCURRED SOMETIME BETWEEN 2010 AND 2012. THE EXACT DATE OF DEATH IS UNK. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE AS A LOT NUMBER WAS MOT PROVIDED. ALL VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS DISCOVERED IN THE LITERATURE BY MEDTRONIC NEUROSURGERY THAT A PT DEVELOPED A SUBDURAL HEMATOMA AFTER A STRATA VALVE WAS IMPLANTED IN THEM TO TREAT THEIR IDIOPATHIC HYDROCEPHALUS. THE PT'S HEMATOMA WAS SURGICALLY DRAINED. THE HEMATOMA, HOWEVER, RECURRED AFTER THE FIRST DRAINAGE, WHICH REQUIRED A SECOND DRAINAGE. AFTER THE SECOND DRAINAGE THERE WAS A PROGRESSION TO SUBDURAL EMPYEMA AND THE PT WAS REPORTED TO HAVE DIED FROM SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240611 UNK STRATA VALVE/SHUNT JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death