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)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient regarding an implanted pump system for non-malignant pain.The pump was used to deliver an unknown drug, dilaudid (hydromorphone) and clonidine.Dose and concentration information was not reported.It was reported that, right after the patient received their handset, the patient noticed that their pump time was incorrect, but the time on the handset was correct.The patient attempted to correct the pump time with their doctor, but the reporter did not know if they fixed it or not.Additional information was received from the patient who reported that after checking with his doctor that filled his pump, adjustments were made, and everything was fine, but now the part that communicated with the pump was slow and it wouldn¿t connect with the pump at times it took several minutes to get a bolus.The ¿counter¿ loses contact when trying to use.The patient also included that per the doctor, the pump time was ¿not off time¿.Additional information was received from the patient who reported that everything has doubled when attempting a bolus and goes through 3 different times to talk to the pump.The patient reported it would just spin until it delivers a bolus and hangs at 91% for over a minute.The patient reported it takes 6-7 minutes to get a bolus.Patient services reviewed best practices with the patient and advised to turn on the communicator second and not first as the patient is doing when first powering up.The troubleshooting steps that were taken on the call resolved the issue.The patient reported that while connecting, the percentage will lag around 91 percent during troubleshooting.However, they were able to connect to the pump.
Additional Manufacturer Narrative
Continuation of d10: 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: 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 ; 7635265677
• MDR Report Key: 24486290
• Report Number: 3004209178-2026-03777
• Device Sequence Number: 20084459
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: (01)00643169530119(17)190814
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: 8637-20
• 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: 03/02/2026
• Date Device Manufactured: 02/15/2018
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 142 KG