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

Model Number	8667-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Muscular Rigidity (1968); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/17/2026
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 receiving gablofen (2000 mcg/ml at 689.5 mcg/day) via an implantable pump for unknown indications for use.It was reported that the patient had their pump replaced on (b)(6) 2026 and then presented on (b)(6) 2026 with withdrawal symptoms.No factors were noted.No actions or interventions have been done at the time of the report, but the patient's healthcare provider (hcp) was planning on giving a bolus of medication if symptoms didn't improve.It was unknown if the issue resolved.Additional information was received from a manufacturer representative (rep) on 2026-aug-31 stating the cause of the withdrawal symptoms was unknown.The specific symptoms the patient experienced were also unknown.Rep was unaware of any additional actions or interventions to resolve the symptoms.It was still unknown if this issue has resolved.Additional information was received from the healthcare provider (hcp) on 2026-sep-01.When asked about specific symptoms the patient experience, the cause of the withdrawal symptoms, the actions/interventions taken to resolve the withdrawal symptoms, and the resolution of the symptoms, the hcp responded with 'please see attached notes' and provided with the medical chart.The medical chart indicated that the patient presented with itching, worsening spasms and muscle cramps, and increased spasticity status post the pump replacement.The patient's symptoms improved significantly after a bolus, suggesting that the pump was likely functional.The hcp indicated that at the time of examination on (b)(6) 2026, they would continue to monitor the patient and titrate the baclofen in the icu to ensure that the patient did not go into withdrawal.The pump was interrogated on (b)(6) 2026 and there were no alarms.A single bolus was given at that time.
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: 50693041
• Report Number: 3004209178-2026-15216
• Device Sequence Number: 9595263
• Product Code: LKK
• UDI-Device Identifier: 00763000999421
• UDI-Public: (01)00763000999421(17)271114
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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?: No
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 05/27/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female