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

Model Number	8637-20
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id a820 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: a820, 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.
Event or Problem Description
Information was received from a consumer regarding a patient receiving morphine via an implanted pump.The indication for pump use was chronic low back pain and non-malignant pain.The patient reported that they were having an issue with getting the ptm (personal therapy manager) to deliver a bolus.The patient stated that when they ¿press or scan up to get it to go to where it says bolus with an arrow, all it does is say 0% and says connecting to pump, but it's not connecting¿.The patient stated that they had charged both devices.The agent assisted the patient in closing the myptm app and reopening it and the patient confirmed they were able to successfully connect to their pump and bolus.While on the call, the patient mentioned that they had had this issue in the past, but it hadn¿t happened where they hadn't been able to finish and connect.The patient stated that it ¿usually scans and stops at 91%¿.The patient also mentioned they sometimes had trouble getting the handset to connect to the communicator.The agent reviewed considerations and redirected the patient to close the app when they are done using it and the patient was going to monitor.

• 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: 24440249
• Report Number: 3004209178-2026-03215
• Device Sequence Number: 13315059
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: (01)00643169530119(17)190628
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/25/2026

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: 06/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• 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: 02/25/2026
• Date Device Manufactured: 01/03/2018
• 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 Sex: Female