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

Model Number	8637-40
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id a820 serial# unknow, product type software.Product id hh9020tdd lot# rf8ra16j4ml.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.
Event or Problem Description
Information was received from a consumer regarding a patient receiving unknown baclofen and bupivacaine via an implanted pump for an unknown indication for use.It was reported the communicator replacement did not resolve their issue.The patient rep clarified the issue was a telemetry issue.Patient would see "connecting" with no other verbiage on the screen and had to tap cancel and relaunch the app again for the ptm to connect to the pump.The patient also was intermittently encountering ¿no pump found¿.The patient rep disabled airplane mode and cleared data of the handset then attempted syncing again.The issue resolved.The last refill was on (b)(6) 2025.A replacement handset was requested from repair.The patient rep called back on (b)(6) 2025 stating the equipment worked 'for a few days' after calling last week but yesterday (b)(6) 2025 and today the patient had been unable to bolus despite the equipment being charged and their data being cleared last week.The patient had the communicator replaced, but never the handset and the han dset must be getting old because the patient¿s pump battery was due to be routinely replaced soon.It was noted the patient had not had any falls/trauma.The agent assisted the caller in navigating to clear data and read the patient¿s data was 176 kb.The caller removed data, and the patient was able to request/receive a bolus.Agent reviewed considerations but agreed to replace handset as part of troubleshooting.A request was sent to repair to replace handset.

• 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 ; 7635265677
• MDR Report Key: 24474017
• Report Number: 3004209178-2026-03613
• Device Sequence Number: 21227797
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: (01)00643169530126(17)200114
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: 01/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/27/2026
• Date Device Manufactured: 07/23/2018
• 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: 2182207-01-24-2025-001-C
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male