BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 7665016 · Received July 5, 2018

    Report

    Report Number
    2021898-2018-00322
    Event Type
    Injury
    Date Received
    July 5, 2018
    Report Date
    July 5, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ALEXANDER VERHAEGHE, STIJN DE MUYNCK, JAN W. CASSELMAN, NIKOLAAS VANTOMME. DELAYED INTRAVENTRICULAR PNEUMOCEPHALUS FOLLOWING SHUNTING FOR NORMAL-PRESSURE HYDROCEPHALUS. WORLD NEUROSURGERY 116 (2018). DOI: 10.1016/J.WNEU.2018.05.112. BACKGROUND: PNEUMOCEPHALUS IS USUALLY SEEN IN TRAUMA OR CRANIAL SURGERY. IT IS RARELY REPORTED AS A DELAYED COMPLICATION OF VENTRICULOPERITONEAL SHUNT PLACEMENT FOR HYDROCEPHALUS SECONDARY TO TRAUMA, TUMOR, OR AQUEDUCT STENOSIS. WE DESCRIBE A CASE OF INTRAVENTRICULAR PNEUMOCEPHALUS MANIFESTING 10 MONTHS AFTER PLACEMENT OF A SHUNT FOR NORMAL-PRESSURE HYDROCEPHALUS. CASE DESCRIPTION: A PRESSURE-REGULATED VENTRICULOPERITONEAL SHUNT WAS IMPLANTED IN AN (B)(6) -YEAR-OLD PATIENT AFTER DIAGNOSIS OF NORMAL-PRESSURE HYDROCEPHALUS. HE SHOWED POSTOPERATIVE CLINICAL IMPROVEMENT. ROUTINE COMPUTED TOMOGRAPHY PERFORMED 2 MONTHS AFTER THE PROCEDURE SHOWED NO ABNORMALITIES. HE PRESENTED 10 MONTHS AFTER SHUNTING WITH A SUBACUTE DETERIORATION OF GAIT. IMAGING REVEALED MAJOR INTRAVENTRICULAR PNEUMOCEPHALUS AND A LEFT-SIDED TEMPORAL PORENCEPHALIC CYST WITH A SMALL, BONY DEFECT IN THE LEFT PETROUS BONE. A MIDDLE FOSSA APPROACH WAS PERFORMED, AND THE TEMPORAL DEFECT WAS COVERED WITH FASCIA OF THE TEMPORAL MUSCLE. THIS RESULTED IN A GRADUAL RESOLUTION OF PNEUMOCEPHALUS. CONCLUSIONS: PNEUMOCEPHALUS AFTER SHUNTING FOR NPH IS RARE AND DESCRIBED AS A COMPLICATION ONLY DURING THE FIRST 2 POSTOPERATIVE MONTHS. THIS CASE IS UNIQUE, AS THE PNEUMOCEPHALUS DEVELOPED 10 MONTHS AFTER SHUNTING. THE COMBINATION OF AN OCCULT, POSSIBLY CONGENITAL, SKULL BASE DEFECT AND THE INSERTION OF A SHUNT RESULTED IN DELAYED INTRAVENTRICULAR AND INTRAPARENCHYMAL PNEUMOCEPHALUS. REPORTED EVENT. A (B)(6) -YEAR-OLD MAN WITH A HISTORY OF A PROSTATE CARCINOMA AND CORONARY STENTING PRESENTED WITH PROGRESSIVE GAIT DISTURBANCES AND URINARY INCONTINENCE. CLINICAL EXAMINATION SHOWED A MAGNETIC GAIT WITHOUT SIGNIFICANT COGNITIVE IMPAIRMENT. A THERAPEUTIC TRIAL OF LEVODOPA WAS INEFFECTIVE. BRAIN MAGNETIC RESONANCE IMAGING SHOWED A COMMUNICATING HYDROCEPHALUS CLINICAL AND IMAGING FINDINGS SUGGESTED NPH. THIS WAS CONFIRMED BY A POSITIVE CEREBROSPINAL FLUID TAP TEST. WE PLACED A PRESSURE-REGULATED VP SHUNT (STRATA II ADJUSTABLE VALVE; MEDTRONIC, (B)(4), USA) WITH THE VALVE AT SETTING 2, CORRESPONDING TO A PRESSURE OF 105 MM H2O IN LYING POSITION. THE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND A SIGNIFICANT IMPROVEMENT OF THE GAIT WAS OBSERVED. THE PATIENT WAS DISCHARGED ON THE THIRD DAY. FOLLOW-UP AT THE OUTPATIENT CLINIC AFTER 8 WEEKS CONFIRMED A FURTHER IMPROVEMENT OF GAIT AND HIS URINARY SYMPTOMS WITH A NORMAL COMPUTED TOMOGRAPHY (CT) SCAN AT THAT TIME. THE PATIENT PRESENTED 10 MONTHS AFTER SHUNT PLACEMENT WITH A BIFRONTAL HEADACHE AND SUBACUTE GAIT DETERIORATION. CT SCAN REVEALED A LARGE INTRAVENTRICULAR PNEUMOCEPHALUS IN THE FRONTAL HORNS OF THE LATERAL VENTRICLES AND IN THE THIRD VENTRICLE AS WELL AS A LEFT-SIDED TEMPORAL PORENCEPHALIC CYST. A HIGH-RESOLUTION CT SCAN OF THE SKULL BASE SHOWED A SMALL DEFECT IN THE LEFT PETROUS BONE IN CLOSE PROXIMITY TO A SMALL INTRAPARENCHYMAL AIR BUBBLE. THIS LED US TO HYPOTHESIZE THAT THE DEFECT WAS PROBABLY THE SITE OF ENTRY OF AIR INTO THE BRAIN. SUBSEQUENTLY, THE MIDDLE FOSSA WAS EXPLORED EXTRADURALLY THROUGH A LEFT TEMPORAL CRANIOTOMY. THE MASTOID DEFECT WAS IDENTIFIED AND COVERED WITH A COLLAGEN SPONGE COATED WITH HUMAN FIBRINOGEN AND THROMBIN COMPLEX (TACHOSIL; (B)(4)). A VASCULARIZED PERICRANIAL FLAP WAS DRAPED OVER THE DEFECT. THE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND IMAGING SHOWED A GRADUAL RESOLUTION OF PNEUMOCEPHALUS WITH IMPROVEMENT OF HIS GAIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506114 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R