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

Model Number	8637-20
Medical Device Problem Codes	No Audible Alarm (1019); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient who was receiving unknown morphine drug and unknown baclofen via an implantable pump for cancer chemotherapy and lumbar radiculopathy.It was reported that  the patient (pt) is in need of a refill that's not scheduled.Pt states he is out of town and has to get to az.Pt wondered if there was any beeping that should take place.Agent reviewed types of alarms.Pt states he got a notification last night that the refill was due for today.Pt states saw service code 97.Pt states says expected refill (b)(6)2206.Pt states on his paperwork shows (b)(6) for the dates of both pumps.Pt states he doesnt have any issues currently and wondered if people will hear the alarm if starts on the plane and if he can fly ok with the alarm if it starts alarming.Agent reviewed and directed to hcp.Pt mentioned its always been that way where they have to removed more medication out, pt states theres always some left over and wondered if there was an extra layer.Pt did not know when that all started.Pt s tates he is going to have the pump filled next week.
Additional Manufacturer Narrative
Continuation of d10: product id 8637-20 lot# serial# (b)(6) implanted: (b)(6) 2022 explanted: product type pump 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: 50804070
• Report Number: 3004209178-2026-15763
• Device Sequence Number: 18789041
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 04/05/2022
• 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...."
• Patient Age: 64 YR
• Patient Sex: Male