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

Model Number	8637-40
Medical Device Problem Codes	Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from the healthcare provider (hcp) via the company representative (rep) regarding a patient receiving intrathecal baclofen (gablofen) 500 mcg/ml at 50 mcg/day via an implantable pump.It was reported that per the managing clinic, the patient developed unexpected withdrawal symptoms during normal use.Per the managing clinic, the patient experienced a fall (date unknown) prior to experiencing withdrawal symptoms.A catheter dye study was attempted (date unknown), but per the managing clinic the catheter could not be aspirated.The existing catheter was found to be leaking at or near the collet between the pump and spinal segments.A catheter revision was scheduled to troubleshoot the implanted system and revise if necessary.Upon opening the pocket, free fluid was observed around the pump.The surgeon then aspirated the catheter via the catheter access port of the old pump and 3ml of clear fluid was withdrawn.However, the surgeon also noticed a clear fluid welling up around the collet between the spinal and pump segments and opted to revise the catheter with a new 8784 revision kit.The pump was also replaced prophylactically, but no complaints were made regarding the pump.The issue resolved at the time of this report.
Additional Manufacturer Narrative
Continuation of d10: product id 8780 lot# serial# (b)(6), implanted: (b)(6) 2017, explanted:.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: (b)(6) 2018, udi#: (b)(4).H3.The returned pump was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.The returned device passed all testing in the laboratory and no anomalies were identified.The returned catheter was subjected to a series of standard tests that include but is not limited to visual inspection, patency testing, and pressure testing.Analysis identified a kink in the catheter body.Analysis identified a hole in the catheter body.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: 50896472
• Report Number: 3004209178-2026-16297
• Device Sequence Number: 17642644
• Product Code: LKK
• UDI-Device Identifier: 00763000634100
• UDI-Public: (01)00763000634100(17)250414
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 09/25/2026

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 Expiration Date: 04/14/2025
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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 Sex: Male