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

Model Number	8637-40
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient via a manufacturing representative (rep) who was receiving fentanyl (2000 mcg/ml at 96.2 mcg /day) via an implantable pump for malignant pain and head/neck (non-malignant).It was reported that the patient came in for a while system pump replacement.In pre-op, the patient informed the rep that they felt a difference in their pain when they weaned them down on their dosing.They also stated that the doses had not been helping as much as when they first had it implanted.The discrepancy reports of the latest refills ranged from 5-10 ml more in the pump than had been expected.The healthcare provider (hcp) was able to aspirate easily off the pump, however upon x-ray with dye intra-op, they saw a kink in the catheter.They decided to replace the catheter and the pump.The issue was resolved at the time of the report.
Additional Manufacturer Narrative
Product analysis #(b)(4):analysis information -- 2026-09-15 09:15:24 cst pli# 30 product id# 8637-40 below is unedited, system generated text based on the analysis finding code(s).The returned device 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.Continuation of d10: product id 8784 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2026 product type catheter product id 8782 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2026 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8784, serial/lot #: (b)(6), ubd: 18-mar-2023, udi#: (b)(4) ; product id: 8782, serial/lot #: (b)(6), ubd: 08-jul-2023, udi#: (b)(4) h3: analysis of the catheter "[s/n:(b)(6)]" found no anomalies were noted on microscopic inspection, the catheter was patent, and passed pressure leak testing.H3: analysis of the catheter "[s/n:(b)(6)]" identified a kink 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: 50820028
• Report Number: 3004209178-2026-15860
• Device Sequence Number: 10152206
• Product Code: LKK
• UDI-Device Identifier: 00763000422615
• UDI-Public: (01)00763000422615(17)221214
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 12/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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: 61 YR
• Patient Sex: Female