BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 25218019 · Received May 19, 2026

    Report

    Report Number
    9612501-2026-01405
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    February 12, 2026
    Report Date
    May 19, 2026
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    KISHORE BALASUBRAMANIAN, DAVID BARKYOUMB, TAYLOR G. BURCH, NICHOLAS SADER, MICHAEL J. FELDMAN, IRA BOWEN, KARL BALSARA, MICHAEL E. OMINI, DAVID S. HERSH, ANDREW JEA. SHORT-TERM CLINICAL OUTCOMES OF CHANGING CSF SHUNT VALVE TYPE OR SHUNT VALVE BRAND IN REVISION SURGERIES FOR THE MANAGEMENT OF PEDIATRIC HYDROCEPHALUS. CHILD¿S NERVOUS SYSTEM 42 (2026). DOI: 10.1007/S00381-026-07168-1 ABSTRACT BACKGROUND AND OBJECTIVE: TO ASSESS WHETHER SWITCHING VALVE TYPE OR VALVE BRAND DURING SHUNT REVISION AFFECTS CLINICAL OUTCOMES IN PEDIATRIC PATIENTS WITH HYDROCEPHALUS. METHODS: PATIENTS AT TWO CENTERS WHO WERE YOUNGER THAN 26 YEARS OF AGE, UNDERWENT A CEREBROSPINAL FLUID (CSF) SHUNT REVISION INVOLVING A VALVE CHANGE, WERE ALIVE AT DISCHARGE, AND HAD AT LEAST ONE DOCUMENTED CLINICAL FOLLOW-UP WITHIN 30 DAYS WERE RETROSPECTIVELY REVIEWED. PATIENTS WHO WERE IMPLANTED WITH A DIFFERENT VALVE TYPE (FIXED VS PROGRAMMABLE) OR BRAND DURING THE SHUNT REVISION WERE COMPARED TO THOSE WHO MAINTAINED THE SAME VALVE TYPE OR BRAND. THE RATES OF SHUNT OBSTRUCTION,INFECTION, OVERDRAINAGE, REOPERATION, READMISSION, AND OTHER COMPLICATIONS WERE ANALYZED. RESULTS: FIFTY-FIVE PATIENTS UNDERGOING 67 SHUNT REVISIONS INVOLVING THE VALVE MET THE INCLUSION CRITERIA. SHORT-TERM (30-DAY) COMPLICATION PROFILES WERE SIMILAR (P = 0.626) WHEN THE VALVE WAS REPLACED WITH ANOTHER VALVE OF THE SAME TYPE (N = 31) VERSUS WHEN A DIFFERENT TYPE WAS IMPLANTED (N = 36). AMONG PATIENTS FOR WHOM THE SAME VALVE TYPE WAS MAINTAINED, THERE WERE NO SIGNIFICANT DIFFERENCES IN POSTOPERATIVE COMPLICATIONS WHEN THE FIXED-PRESSURE VALVE BRAND WAS CHANGED (N = 7) COMPARED TO WHEN THE SAME BRAND WAS REPLACED (N = 12) (P = 0.678). CHANGING THE PROGRAMMABLE VALVE BRAND (N = 6) RESULTED IN A SIGNIFICANTLY LOWER RATE OF COMPLICATIONS (P = 0.025), SPECIFICALLY FEWER FREQUENT SHUNT OBSTRUCTIONS (P = 0.025), COMPARED TO WHEN THE SAME PROGRAMMABLE VALVE BRAND WAS REPLACED (N = 11). CONCLUSION: IN THIS TWO-CENTERCOHORT OF SHUNT REVISIONS INVOLVING THE VALVE, CHANGING THE VALVE TYPE OR BRAND WAS NOT ASSOCIATED WITH DIFFERENCES IN EARLY (30-DAY) COMPLICATION RATES. A SIGNIFICANT TREND TOWARD FEWER COMPLICATIONS AFTER CHANGING THE PROGRAMMABLE VALVE BRAND WAS OBSERVED IN A SMALL SUBGROUP AND SHOULD BE INTERPRETED AS HYPOTHESIS-GENERATING. LARGER, LONGER-TERM STUDIES ARE NEEDED TO DETERMINE THE IMPACT OF VALVE CHOICE ON SHUNT SURVIVAL AND LONG-TERM OUTCOMES. REPORTED EVENTS - THE PRIMARY INDICATIONS FOR REVISION WERE UNDERDRAINAGE (N = 25, 37%), OVERDRAINAGE (N = 11, 16%), INFECTION (N = 8, 12%), SHUNT MALFUNCTION (N = 7, 10%), PROXIMAL CATHETER DISCONNECTION/MIGRATION (N = 7, 10%), WOUND DEHISCENCE (N = 4, 6%), AND OTHER (DISTAL CATHETER DISCONNECTION N = 1, PSEUDOMENINGOCELE N = 1, ETV FAILURE N = 1, RECURRENT PLEURAL EFFUSIONS N = 1, APPENDICITIS REQUIRING SHUNT EXTERNALIZATION N = 1) (N = 5, 7%). THE COMPONENTS REVISED MOST FREQUENTLY INCLUDED THE PROXIMAL CATHETER AND VALVE (N = 27, 40%); VALVE ONLY (N = 20, 30%); PROXIMAL CATHETER, VALVE, AND DISTAL CATHETER (N = 14, 21%); AND DISTAL CATHETER AND VALVE (N = 6, 9%). OF THE 20 CASES THAT REQUIRED REVISION OF ONLY THE VALVE, 10 (50%) WERE TO ADDRESS VALVE OBSTRUCTION, 5 (25%) WERE TO MANAGE CLINICAL SYMPTOMS UNRELATED TO SHUNT SYSTEM MALFUNCTION, 4 (20%) WERE TO ADDRESS OVERDRAINAGE, AND IN 1 (5%) CASE, A PATIENT REQUESTED A D IFFERENT TYPE OF VALVE. COMPLICATIONS OCCURRED IN 26 (39%) OF THE 67 REVISIONS. FIFTEEN (58%) OF THESE COMPLICATIONS WERE CLASSIFIED AS GRADE 1, 10 (38%) AS GRADE 2, AND 1 (4%) AS GRADE 3. THE MOST COMMON COMPLICATIONS OBSERVED WERE SHUNT OBSTRUCTION (N = 13, 19%), READMISSION WITHIN 30 DAYS (N = 12, 18%), NEW NONPOSTURAL HEADACHE (N = 9, 13%), PSEUDOMENINGOCELE (N = 5, 7%), WOULD DEHISCENCE/SUPERFICIAL INFECTION (N=5, 7%), SHUNT OVERDRAINAGE (N = 4, 6%), SHUNT INFECTION (N = 3, 4%), AND NEUROLOGICAL DYSFUNCTION (SEIZURES) (N = 3, 4%). THREE CASES (4%) REQUIRED REOPERATION WITHIN SEVEN DAYS FOR EARLY SHUNT FAILURE. MEDTRONIC STRATA, DELTA, AND CSF FLOW CONTROL DEVICES ALONG WITH OTHER MANUFACTURERS WERE MENTIONED IN THE ARTICLE, HOWEVER, IT WAS NOT INDICATED WHICH MANUFACTURER/DEVICE WAS ASSOCIATED WITH THE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523265 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1