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

Model Number	8637-40
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient who was receiving baclofen (unknown concentration, unknown dosage) via an implantable pump for unknown indication.It was reported that the during pump replacement, when the cap was being aspirated and flushed, the proximal pump segment was leaking where the catheter attached to the pump.The physician decided to replace the pump segment at that time.The physician was asked if he wanted to ship the old pump segment for evaluation.The physician declined and the old pump segment was discharged.The issue was resolved at the time of the report.The healthcare provider (hcp) had no further information for the manufacturer.
Additional Manufacturer Narrative
Continuation of d10: product id 8780 lot# serial# (b)(6), implanted: (b)(6) 2020, explanted: (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: 08-nov-2021, 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 II
• 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: 50871827
• Report Number: 3004209178-2026-16165
• Device Sequence Number: 13447537
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: (01)00643169630512(17)210628
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 01/08/2020
• 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...."
• Patient Age: 36 YR
• Patient Sex: Female