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

Model Number	8637-20
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Cognitive Changes (2551)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Information was received from a consumer (con) regarding a patient receiving baclofen via implantable pump.The indication use was i ntractable spasticity.It was reported that they refilled her pump two weeks ago and increased the rate.It was sent to deliver a bolus daily, but now the pump is rapidly alarming.The patient stated that they did intense physical therapy today where they had her strapped up into all sorts of contraptions and it was hurting a little bit, but they put a gel pack on it, so it went rubbed but they think they were probably rubbed.The patient also mentioned that they have a very bad urinary tract infection (uti) so they thought that was what it was, but they need to figure out where to get it checked because they had gone through withdrawals twice in her life in 20 years and it scares her to death because her mental state is severely altered.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider (hcp) to further address the issue.The patient stated that the hcp was closed but they spoke to the nurse who directed the patient to the emergency room (er).The patient mentioned that they have a traumatic brain injury.

• 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 ; 7635265677
• MDR Report Key: 21753630
• Report Number: 3004209178-2025-05707
• Device Sequence Number: 8263867
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: 10/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/17/2026
• Date Device Manufactured: 04/20/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2182207-11-22-2024-006-C
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female