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

Model Number	8637-40
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Codes	Diarrhea (1811); Pain (1994)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiv ing bupivacaine (10 mg/ml at 14.393 mg/day) and unknown morphine drug (15 mg/ml at 14.393 mg/day) via an implantable pump for non-malignant pain indications for use.It was reported that the patient had a refill on (b)(6)2026.Caller stated the pump was at 5.6ml when patient came in for the refill, and it was filled to 40%.Caller verified the pump was not alarming when pt was in for refill.Caller stated that today, the patient contacted their pain office and said the pump was alarming every 10 minutes since this morning.Patient does not have a controller/personal therapy manager.Patient stated they did not have any external devices near the pump area over the past 2 days that could have produced electromagnetic interference.Patient was unsure when the pump started to alarm, but they noticed it this morning. patient reported they were in more pain last night but when they tried to ask more about their pain, the patient said they are always in pain. patient also said they had diarrhea this morning which was not normal for them.The issue was not resolved through troubleshooting.Caller stated that a nurse will read the pump logs today to determine the cause for the pump alarm.Later, the healthcare provider (hcp) called in to report alarm codes 232 and 100, consistent with motor stall.Technical services reviewed pump motor stall information and considerations.
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: 50857650
• Report Number: 3004209178-2026-16054
• Device Sequence Number: 10025996
• Product Code: LKK
• UDI-Device Identifier: 00763000634100
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 12/14/2024
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 06/16/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Female