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

Model Number	8667-40
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Ambient Temperature Problem (2878)
Health Effect - Clinical Codes	Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider and a manufacturing representative regarding a patient was receiving unknown morphine via an implantable pump for spinal pain.It was reported that the caller reported that the patient had an mri today (b)(4) and when they started the mri, the patient felt a heat and warmth that started from the pump and went across.The caller stated the patient pushed the button and the pump was only off for about 15 minutes and then it restarted on its own.The caller confirmed the warmth had gone away and there were no other symptoms of burning or pain, just that the pump was slightly warm to touch over top of it.The caller asked if this was normal.The caller also stated during imaging that the pump was not completely flat on the patient body but not 90 degree towards the axis.The agent reviewed mri labeling and pump location with caller.
Event or Problem Description
Additional information was received from the healthcare provider (hcp).It was reported that the cause of the pump not lying completely fiat against the patient's body, but not 90 degrees towards the axis, was determined.The pump not lying completely fiat against the patient's body was resolved on its own.It was further reported that the warmth over the pump and the slight warmth to the touch over the top resolved on their own.
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.
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 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: 50936863
• Report Number: 3004209178-2026-16548
• Device Sequence Number: 18828640
• Product Code: LKK
• UDI-Device Identifier: 00763000597030
• UDI-Public: (01)00763000597030(17)270414
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 8667-40
• Device Catalogue Number: 8667-40
• 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: 09/18/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 10/17/2025
• 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
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female