BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC LUMBOPERITONEAL SHUNT KIT

    MDR report key: 10886921 · Received November 23, 2020

    Report

    Report Number
    2021898-2020-00349
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    March 1, 2015
    Report Date
    April 28, 2021
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K091312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MADOKA NAKAJIMA, MASAKAZU MIYAJIMA, IKUKO OGINO, HIDENORI SUGANO, CHIHIRO AKIBA, NAOKO DOMON, KOSTADIN L. KARAGIOZOV, HAJIME ARAI. USE OF EXTERNAL LUMBAR CEREBROSPINAL FLUID DRAINAGE AND LUMBOPERITONEAL SHUNTS WITH STRATA NSC VALVES IN IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS: A SINGLE-CENTER EXPERIENCE. WORLD NEUROSURGERY 83 (2015). DOI: 10.1016/J.WNEU.2014.08.004 OBJECTIVE: IN JAPAN, IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH) CURRENTLY IS TREATED MAINLY WITH LUMBOPERITONEAL (LP) SHUNTS. OUR AIM WAS TO EVALUATE WHETHER LP SHUNTING VIA THE USE OF MEDTRONIC STRATA NSC PROGRAMMABLE VALVES WAS AS EFFECTIVE AS VENTRICULOPERITONEAL SHUNTING IN THE TREATMENT OF PATIENTS WITH INPH FROM THE PERSPECTIVES OF SAFETY AND SYMPTOMATIC IMPROVEMENT RATE. METHODS: THE CLINICAL RECORDS OF 51 INPH PATIENTS (MEAN AGE, 75 YEARS; MALES, 29), WHO UNDERWENT PLACEMENT OF MEDTRONIC STRATA NSC LP SHUNT SYSTEMS WERE REVIEWED RETROSPECTIVELY AS A COHORT. LP SHUNTING WAS EVALUATED WITH THE MODIFIED RANKIN SCALE, THE JAPAN NORMAL-PRESSURE HYDROCEPHALUS GRADING SCALE, THE MINI-MENTAL STATE EXAMINATION, THE FRONTAL ASSESSMENT BATTERY, AND THE TRAIL-MAKING TEST A AS OUTCOME MEASURES. RESULTS: MODIFIED RANKIN SCALE SCORES IMPROVED FROM 3.2 TO 2.2 (P< 0.01), INDICATING A 64% RESPONSE RATE 12 MONTHS AFTER TREATMENT. TOTAL JAPAN NORMAL- PRESSURE HYDROCEPHALUS GRADING SCALE SCORES DECREASED FROM 6.5 TO 4.0 (P <.01), INDICATING A RESPONSE RATE OF 81%. MINI-MENTAL STATE EXAMINATION SCORES IMPROVED FROM 22.2 TO 25.4 (P < 0.01), FRONTAL ASSESSMENT BATTERY SCORES IMPROVED FROM 11.7 TO 13.4 (P < 0.05), AND TRAIL-MAKING TEST A SCORES IMPROVED FROM 122.3 TO 112.7 (P [ 0.60). DURING THE 12-MONTH FOLLOW-UP PERIOD, COMPLICATIONS REQUIRING SURGERY WERE OBSERVED IN 6 CASES (11.8%). CONCLUSION: LP SHUNTS SHOWED EFFECTIVENESS RATES THAT WERE SIMILAR TO THOSE OF VENTRICULOPERITONEAL SHUNTS. DESPITE THE RELATIVELY HIGH COMPLICATION RATE, LP SHUNTS CAN BE RECOMMENDED FOR THE TREATMENT OF PATIENTS WITH INPH BECAUSE OF THEIR MINIMAL INVASIVENESS AND LACK OF LETHAL COMPLICATIONS. REPORTED EVENTS. - OVERDRAINAGE WAS OBSERVED IN 6 CASES. ALL WERE IMPROVED BY ADJUSTMENT OF THE VALVE PERFORMANCE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349185 STRATA NSC LUMBOPERITONEAL SHUNT KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 44421 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1