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 Code	Insufficient Information (4580)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiv ing unknown baclofen via an implantable pump for intractable spasticity.It was reported that the patient was displaying withdrawal symptoms and a dye study was completed and failed.The physician decided to implant an entire new catheter which resolved the issue.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name ascenda; product id 8780 (serial: (b)(6)); product type: 0184-catheter; implant date (b)(6) 2020; explant date (b)(6) 2026 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: 50869091
• Report Number: 3004209178-2026-16121
• Device Sequence Number: 15781369
• Product Code: LKK
• UDI-Device Identifier: 00763000999414
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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
• Report Date (Section B): 09/23/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 05/18/2026
• 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
• Patient Age: 37 YR
• Patient Sex: Male