BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 10596201 · Received September 28, 2020

    Report

    Report Number
    2021898-2020-00248
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    April 11, 2020
    Report Date
    September 28, 2020
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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

    TZE-WEI CHANG, PAO-HUI TSENG, YI-CHENG WANG, GUO-FANG TSENG, TSUNG-LANG CHIU, SHINN-ZONG LIN AND SHENG-TZUNG TSAI. DOPAMINERGIC DEGENERATION AND SMALL VESSEL DISEASE IN PATIENTS WITH NORMAL PRESSURE HYDROCEPHALUS WHO UNDERWENT SHUNT SURGERY. JOURNAL OF CLINICAL MEDICINE 9 (2020). DOI:10.3390/JCM9041084 ABSTRACT: THE DIAGNOSIS OF IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH) AND THE OUTCOME OF LUMBOPERITONEAL SHUNT TREATMENT REMAINS TO BE SYSTEMATICALLY EXPLORED. HERE, WE AIM TO EVALUATE WHETHER THE SEVERITY OF DOPAMINERGIC DEGENERATION AND WHITE MATTER SMALL VESSEL DISEASE COULD BE PREDICTORS OF OUTCOME FOR INPH PATIENTS SUBJECTED TO LUMBOPERITONEAL SHUNT TREATMENT. THIS IS A SINGLE CENTER RETROSPECTIVE STUDY WITH 39 PATIENTS WITH PROBABLE INPH UNDERGOING PROGRAMMABLE SURGICAL LUMBOPERITONEAL SHUNT FROM JUNE 2016 TO MARCH 2018 AT HUALIEN TZU CHI HOSPITAL. IN ALL PATIENTS, DOPAMINERGIC DEGENERATION WAS DETERMINED WITH 99MTC- TRODAT-1 SPECT SCAN, WHILE WHITE MATTER SMALL VESSEL DISEASE (FAZEKAS SCALE) WAS ASSESSED WITH BRAIN MRI. THE INPH GRADING SCALE (INPHGS) SCORE AND KARNOFSKY PERFORMANCE SCORE (KPS) PRE- AND POST-OPERATION (6-MONTH FOLLOW-UP) WERE AVAILABLE FOR ALL PATIENTS. LINEAR REGRESSION WAS USED TO CORRELATE THE SEVERITIES OF DOPAMINERGIC DEGENERATION AND SMALL VESSEL DISEASE WITH LUMBOPERITONEAL SHUNT TREATMENT OUTCOMES. THEIR INPHGS SCORE IMPROVED SIGNIFICANTLY AFTER SURGERY (PRE-OPERATIVELY, 7.8 2.6; POST-OPERATIVELY, 5.7 2.6 (26.9% IMPROVEMENT) (P <(><<)> 0.05)). MOREOVER, THE KPS WAS ALSO IMPROVED SIGNIFICANTLY AFTER SURGERY, BY A MEAN OF 24.6% FROM THE BASELINE SCORE (P <(><<)> 0.05). A SIGNIFICANT CORRELATION WAS OBSERVED BETWEEN THE SEVERITY OF DOPAMINERGIC DEGENERATION AND A POORER IMPROVEMENT OF INPHGS SCORE (P = 0.03). HOWEVER, IMPROVEMENT OF THE INPHGS SCORE WAS NOT CORRELATED WITH WHITE MATTER SMALL VESSEL DISEASE. DOPAMINERGIC DEGENERATION COMORBIDITY NEUTRALIZED THE DEGREE OF IMPROVEMENT AFTER SURGERY. ALTHOUGH WHITE MATTER SMALL VESSEL DISEASE WAS CORRELATED WITH INPH INCIDENCE, IT MAY NOT BE A PROGNOSTIC FACTOR FOR SHUNT OPERATION. THESE FINDINGS HAVE IMPLICATIONS FOR THE USE OF DOPAMINERGIC IMAGING, AS THEY MIGHT HELP PREDICT THE SURGICAL OUTCOME OF PATIENTS WITH INPH, WHILE VASCULAR MECHANISMS SEEM TO BE INVOLVED IN INPH PATHOPHYSIOLOGY. REPORTED EVENTS. - THERE WERE THREE CASES OF NON-SERIOUS ADVERSE EFFECTS, INCLUDING POSITIONAL HEADACHE, INTERMITTENT NECK STIFFNESS AND ASYMPTOMATIC SUBDURAL FLUID COLLECTION. ALL OF THESE COMPLAINTS RESOLVED AFTER INCREASING THE PRESSURE SETTING OF THE SHUNT RESERVOIR. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060267 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1