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

Model Number	8637-20
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturer's representative (rep) regarding a patient receiving bupivacaine (15mg/ml at.742mg/day) and morphine (20mg/ml at.989mg/day) via an implantable infusion pump for spinal pain indications for use.It was reported that the patient had a refill on (b)(6)2026 and the session report read that the end of service (eos) date was (b)(6) 2026.The rep stated the patient heard the pump start alarming (b)(6)2026 and symptoms began today, (b)(6)2026, and the patient was in the emergency room (er) now.The rep stated that the patient was having withdrawal symptoms.Technical services reviewed that based on the implant date, eos at this time would be expected.The rep read the logs, and the elective replacement indicator (eri) date was (b)(6)2026 and the eos date was (b)(6)2026.Technical services was unable to explain why the logs were reading incorrect eri and eos dates.Technical services reviewed that the pump would need to be replaced and the reports investigated further.The session report from (b))(6)2026 indicated the estimated eos date was (b)(6)2026 and indicated in the logs a non-critical alarm for eri on (b)(6)2026 at 12:13pm.It was noted in the logs that there was a motor stall (b)(6)2026 at 10:11am and 2:34pm, with subsequent recoveries at 10:43am and 2:54pm, respectively.The session report from (b)(6)2026 indicated that eos occurred (b)(6)2026 at 7:11am and the pump was programmed and permanently shut down (b)(6)2026 at 7:39pm.**see related event (b)(4) regarding motor stalls in logs** (b)(6)2026 e1 (rep, hcp): document contained no new information regarding this event.
Additional Manufacturer Narrative
Continuation of d10: product id (b)(4)lot# serial# unknown implanted: explanted: product type software section d information references the main component of the system.Other relevant device(s) are: product id: a810, serial/lot #: unknown, ubd: , udi#: 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: 50194399
• Report Number: 3004209178-2026-13376
• Device Sequence Number: 15947792
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: (01)00643169530119(17)190828
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 08/28/2019
• 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: 08/10/2026
• Initial Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 03/07/2018
• 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: 2182207-11-22-2024-006-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Patient Age: 58 YR
• Patient Sex: Female