MAUDE Adverse Event Report: MEDTRONIC DOMINICANA DELTA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	25131-5
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Apnea (1720); Hydrocephalus (3272); Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received information regarding a valve/shunt.It was reported that despite the presence of pressured cerebrospinal fluid (csf), when the proximal side of the shunt was implanted in the patient, no csf flow was observed from the distal end when the pump and distal end were connected.Even when the tip was lowered below the ventricle level, no csf flow was observed despite the flow of csf by pumping.The patient was placed on drainage and an adjustable shunt was implanted.The patient's status at the time of the report was alive-no injury.
Event or Problem Description
Additional information received reported that the patient developed hydrocephalus because the shunt did not function after the procedure.The patient experienced epileptic seizures and spontaneous respiratory loss and was connected to mechanical ventilators, that in patient undergoing revision, an evd had to be inserted, on grounds the shunt was seen to be functioning by pumping.
Additional Manufacturer Narrative
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.

• Brand Name: DELTA®
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 22839498
• Report Number: 9612501-2025-02178
• Device Sequence Number: 17349083
• Product Code: JXG
• UDI-Device Identifier: 00763000027957
• UDI-Public: (01)00763000027957(17)290517(10)0229070311
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25131-5
• Device Catalogue Number: 25131-5
• Device Lot Number: 0229070311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 08/27/2025
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male