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

Model Number	8637-40
Medical Device Problem Codes	Filling Problem (1233); Insufficient Flow or Under Infusion (2182); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Itching Sensation (1943); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient who was receiving unknown morphine drug and clonidine via an implantable pump for spinal pain indications for use.It was reported that the patient (pt) had morphine and clonidine.With the morphine, they were beginning to itch really bad.Pt expressed concern that the pump was not functioning properly and that they were not receiving the medication as intended.Pt asked if the itching could be a side effect of the morphine.Pt mentioned that they had researched online and found that both morphine and clonidine could potentially cause itching.When asked about the event date, pt stated they were having more problems when the pump was replaced.Pt mentioned during their refill on (b)(6)2026, the healthcare provider (hcp) removed the existing medication and refilled the pump with new medication.Pt further stated that "35 cc was withdrawn from the pump and left 5 cc, so for few months i wasn't getting any medication, except 5% and that was very low for me." agent reviewed information and redirected pt to the hcp.Pt stated that they already told their doctor during their refill, and they were advised that morphine was not the side effect of their itching and "it" may work to get them through or not; however, pt said that the itching was almost unbearable.Agent offered to send physician listings via email.
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 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: 50839228
• Report Number: 3004209178-2026-15926
• Device Sequence Number: 10039692
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 02/14/2021
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 08/21/2019
• 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
• Patient Sex: Female