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	Pain (1994)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id 8780; lot/serial#: (b)(6); implanted: (b)(6) 2025; 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: 14-may-2027; 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.
Event or Problem Description
Information was received from a consumer and a healthcare provider via a company representative regarding a patient receiving dilaudid (3 mg/ml at 0.2 mg/day) via an implanted pump.The patient¿s medical history included multiple fusions and thoracic and lumbar hardware in spine t9 through l5, right knee replacement, left hip replacement, high blood pressure controlled with medication, and acid reflux.The indication for pump use was back pain with leg pain and non-malignant pain.The patient reported diminished pain relief following initial implant and subsequent titration of the patient¿s daily dose.There were no reported environmental, external, or patient factors that may have led or contributed to the issue.A catheter dye study was attempted in (b)(6) 2026, but the catheter could not be aspirated, so no dye study was able to be performed.The patient was then referred to the neurosurgeon for possible catheter revision or replacement of the catheter due to the amount of hardware the patient had implanted and the difficulty of catheter placement with the initial implant.On (b)(6) 2026, the patient was taken to surgery, and the catheter could not be aspirated through catheter access port.The surgeon freed up the coiled catheter beneath the pump in the pump pocket, but the catheter would still not aspirate.The surgeon cut the pump catheter segment behind the pin, and he replaced the pump segment of the catheter and the connector.Following the revision, the surgeon was able to successfully aspirate the catheter.The pump was then reinserted into the pump pocket and the incision was closed.Prior to closing the surgeon performed a catheter dye study and determined that the catheter was in the intrathecal space in a posterior position.The catheter tip was noted at t10.The daily dose was reduced by 37% from what was programmed prior to the revision procedure today.This dose reduction was directed by the surgeon and the managing physician.The pump programming was completed prior to leaving the or (operating room) and verified by the surgeon.The issue was noted to be resolved.
Additional Manufacturer Narrative
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 ; 7635265677
• MDR Report Key: 24741555
• Report Number: 3004209178-2026-05633
• Device Sequence Number: 9060598
• Product Code: LKK
• UDI-Device Identifier: 00763000597023
• UDI-Public: (01)00763000597023(17)261128
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 06/03/2025
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 68 KG