BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 23832270 · Received December 17, 2025

    Report

    Report Number
    9612501-2025-03383
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    June 13, 2025
    Report Date
    December 17, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    MORITZ UEBERSCHAER, KATJA WIRTHENSOHN, SEBASTIAN NIEDERMEYER, ROBERT FORBRIG, NIKLAS THON, MATHIAS KUNZ, AND MICHAEL SCHMUTZER-SONDERGELD. COMPARISON OF ENDOSCOPIC THIRD VENTRICULOSTOMY WITH STEREOTACTIC PREPONTINE STENTING IN PATIENTS WITH AQUEDUCTAL STENOSIS. JOURNAL OF NEUROSURGERY (2025). DOI: 10.3171/2025.2.JNS242984 OBJECTIVE THE STANDARD TREATMENT FOR NONCOMMUNICATING HYDROCEPHALUS IS ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV). AN ALTERNATIVE PROCEDURE IS THE STEREOTACTIC IMPLANTATION OF A SHUNT CATHETER THROUGH THE VENTRICLES INTO THE PREPONTINE CISTERN, WHICH SERVES AS A STENT (STS). THIS PROCEDURE MAY REDUCE THE RISK OF STOMA OCCLUSION. THE AIM OF THIS STUDY WAS TO COMPARE THE SURGICAL AND CLINICAL RESULTS OF BOTH PROCEDURES. METHODS PATIENTS WITH AQUEDUCTAL STENOSIS TREATED BY EITHER ETV OR STS FROM JANUARY 2013 TO JULY 2024 WERE INCLUDED IN THIS SINGLE-CENTER RETROSPECTIVE STUDY. PATIENT RECORDS WERE SEARCHED FOR INDICATION, PROCEDURAL DATA, COMPLICATIONS, AND CLINICAL OUTCOMES. IN ADDITION, AVAILABLE MR IMAGES WERE ANALYZED FOR THE EVANS INDEX, BASILAR ARTERY TO CLIVUS DISTANCE, AND VENTRICULAR WIDTH. THE PARAMETERS WERE COMPARED BETWEEN ETV AND STS GROUPS. RESULTS STS WAS PERFORMED IN 50 PATIENTS WITH A MEAN AGE OF 46 YEARS AND ETV IN 97 PATIENTS WITH A MEAN AGE OF 36 YEARS. STS WAS CARRIED OUT MORE FREQUENTLY IN PATIENTS WITH SECONDARY AQUEDUCTAL STENOSIS DUE TO A TUMOR (66% VS 21%), WHILE ETV WAS CONDUCTED MORE FREQUENTLY IN PATIENTS WITH PRIMARY AQUEDUCTAL STENOSIS (76% VS 26%). THE DISTANCE BETWEEN THE BASILAR TIP AND CLIVUS WAS SIGNIFICANTLY SMALLER IN THE STS GROUP (2.8 VS 3.7 MM, P = 0.0007). THE MOST COMMON SYMPTOMS BEFORE SURGERY IN BOTH GROUPS WERE HEADACHES (48%), COGNITIVE IMPAIRMENT (46%), AND GAIT DISORDER (48%). BOTH PROCEDURES RESULTED IN SIGNIFICANT IMPROVEMENT OF SYMPTOMS. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE NUMBER OF REVISION SURGICAL PROCEDURES DUE TO INFECTION OR BLEEDING (STS 8% VS ETV 4%) OR INSUFFICIENCY OF THE HYDROCEPHALUS TREATMENT (STS 4% VS ETV 13%, P = 0.09). SUBGROUP ANALYSES THAT EXCLUDED NEWBORNS AND STRATIFIED RESULTS BY ETIOLOGY OF AQUEDUCTAL STENOSIS HAD NO EFFECT ON THE RESULTS. CONCLUSIONS THE SAFETY AND EFFICACY OF BOTH SURGICAL PROCEDURES ARE COMPARABLE. THE SELECTION OF THE SURGICAL APPROACH MUST BE MADE ON AN INDIVIDUAL BASIS. REPORTED EVENTS - IN THE STS GROUP, REVISIONS DUE TO INSUFFICIENT DRAINAGE TENDED TO BE LESS FREQUENT (2/50 [4%] VS 13/97 [13%], P = 0.09). IN CASE OF INSUFFICIENT DRAINAGE, A SECOND SURGERY WAS PERFORMED TO CONNECT A PERITONEAL CATHETER TO THE DISTAL END OF THE STS CATHETER. IN 2/50 (4%) CASES, REVISION SURGERY WAS PERFORMED DUE TO WOUND-HEALING PROBLEMS. ANOTHER 2 PATIENTS REQUIRED TRANSIENT EXTERNAL VENTRICULAR DRAIN PLACEMENT FOLLOWED BY VP SHUNT BECAUSE OF PERIPROCEDURAL BLEEDING. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245948 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention