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

Model Number	8667-20
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient who was receiving morphine drug via an implantable pump for spinal pain indications.It was reported that the handset was not working.They said that they got stimulation every 3 hours "[understood to be boluses]".The patient said the issue started about 3 weeks ago.The patient mentioned they keep a timer on the handset, and the timer was never the correct time for one.The agent asked if patient has recently had a change in her therapy and patient said they just filled the pump yesterday and they increased the amount of medication that it was going to administer, but they didn't change the time.During the call, the patient stated it started connecting out of the blue, and the patient stated at times it took 20 minutes to connect, and it sat at 90%.They stated it would work when it wanted to.The agent walked the patient through clearing the data.The patient was able to connect to the application.The troubleshooting steps that were taken on the call resolved the issue.
Additional Manufacturer Narrative
Continuation of d10: product id a820 lot# serial# unknown implanted: explanted: product type software product id hh90t01 lot# serial# rf8t607xl9k implanted: explanted: product type mobile platform section d information references the main component of the system.Other relevant device(s) are: product id: a820, serial/lot #: unknown.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 ; +1(763)526-5677
• MDR Report Key: 50913941
• Report Number: 3004209178-2026-16376
• Device Sequence Number: 12200688
• Product Code: LKK
• UDI-Device Identifier: 00763000597023
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Model Number: 8667-20
• Device Catalogue Number: 8667-20
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 10/24/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2182207-01-24-2025-001-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Patient Age: 73 YR
• Patient Sex: Female