MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SynchroMed III; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8667-20
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Apnea (1720); Fluid Discharge (2686); Insufficient Information (4580)
Date of Event	08/28/2026
Type of Reportable Event	Death
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving gablofen (1,000mcg.Ml at 250mcg/day) via an implantable pump for unknown indications for use.It was reported that the patient was having withdrawal symptoms.Patient was titrated by managing physician.A dye study was done and they could not aspirate the cath eter.The catheter was completely replaced and the issue was resolved.Death isn¿t confirmed to have anything to do with pump or the surgery as managing physician didn¿t have details.Additional information was received from the healthcare provider (hcp) stating the patient experienced withdrawal symptoms and a catheter dye study was done, at which time the catheter could not be aspirated.On (b)(6) 2026, the patient underwent intraventricular catheter revision.The patient was seen on (b)(6) 2026 and was doing well at that time.The patient was not in withdrawal and no dosing changes were made.Also at that time, it was noted that there was some fluid around the incision site on the scalp, but it was unknown what the fluid was as it was not sampled.The hcp indicated that it was likely serosanguinous fluid typical of a wound.On (b)(6) 2026, the patient was reported to be very fussy and then went into respiratory arrest, was taken to an offsite hospital and passed away.Autopsy is in progress and the cause of death was not clear.
Additional Manufacturer Narrative
Continuation of d10: product id 8780, serial# (b)(6), implanted: (b)(6) 2026, explanted: (b)(6) 2026, product type catheter product id 8780, serial# (b)(6), implanted: (b)(6) 2026.Product type catheter product id 8780 serial# (b)(6) implanted: (b)(6) 2026.Product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(6), ubd: 19-jul-2026, udi#: (b)(4).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: SynchroMed III
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 50900308
• Report Number: 3004209178-2026-16344
• Device Sequence Number: 17618207
• Product Code: LKK
• UDI-Device Identifier: 00763000597023
• UDI-Public: (01)00763000597023(17)270128
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: 8667-20
• Device Catalogue Number: 8667-20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/25/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: See H11.
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 6 YR
• Patient Sex: Male