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

Model Number	8637-40
Medical Device Problem Codes	Application Program Problem (2880); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id tm90t0 serial# (b)(6) product type accessory product id hh90t01 serial# (b)(6) product type mobile platform product id hh90t01 serial#(b)(6) product type mobile platform product id a820 serial# unknown product type software product id a820 serial# unknown product type software section d information references the main component of the system.Other relevant device(s) are: product id: a820, serial/lot #: unknown; 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 an unknown drug via an implantable pump for non-malignant pain.It was reported that the patient had encountered a message on the personal therapy manager (ptm) application six times where it says "system error - the system has encountered an unexpected error, contact technical support." they thought there was a code listed as well but they did not know the specific code.Patient services walked them through steps to reboot the handset and communicator.They were then able to successfully deliver a bolus.The troubleshooting steps that were taken on the call resolved the issue.Additional information was received from the consumer who reported that they had seen a system error message (code unknown) about 7 times and had not been able to use their ptm.When they tried to connect, it seemed that the location of where they held the communicator had moved.It would get stuck at 91% and take a long time to connect afterwards.Patient services clarified and the patient confirmed that the pump itself had not moved.Patient services assisted them to reset the device/software and the issue was resolved.Additional information was received from the consumer who reported that on the ptm application on their handset they were getting a persistent system error code 0x5ffa001d.The issue had been ongoing.This morning following the system error, they experienced communication error 356 on screen.Patient services reviewed this may have resulted from interruption made by the system error.The patient stated the issue was getting worse and they were extremely frustrated.Email sent to repair for handset replacement.Additional information was received from the consumer who reported that they were still having the same issue when trying to deliver boluses with their new ptm application/handset and communicator.Now they were seeing system error code 0x2dd6c11a with the same communication error 356.They stated they kept both devices charged.Agent reviewed not to use wi-fi.The connection was still getting stuck at 91% when placing the communicator to connect to the pump.They also stated their handset wallet strap was broken.Email sent to repair for handset, communicator, and handset wallet replacement.

• 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: 24454847
• Report Number: 3004209178-2026-03418
• Device Sequence Number: 10007105
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: (01)00643169530126(17)190814
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/26/2026

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: 08/14/2019
• 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: 02/26/2026
• Date Device Manufactured: 02/27/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 37 YR
• Patient Sex: Female