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

Model Number	8637-20
Medical Device Problem Codes	Application Program Problem (2880); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id a820 lot# 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.
Event or Problem Description
Information was received from a patient who was receiving sufentanil and fentanyl via an implantable pump for non-malignant pain.It was reported that the patient had software version 2.0.1700.The reason for call was the patient had a refill a couple days ago and they noticed the refill date was running backwards on the handset, the date was showing (b)(6) 2025.The patient asked how to fix the alarm date on the handset.The patient reported the device takes a long time to connect to deliver a bolus and device gets stuck at 90%, since they had the device.The patient disliked the new personal therapy manager (ptm) and loved the old ptm.The patient heard a lot of people have problems with the new ptm.The patient's next refill was (b)(6) 2025.It was noted the patient get 10 boluses a day.Patient service assisted the patient with resetting the communicator and clearing the data on the handset.Agent asked the patient to connect to the implant and the device connected very fast to the implant, showing a lockout screen.The troubleshooting steps that were taken on the call resolved the issues.The patient was redirected to their healthcare provider to further address the alarm date.The patient mentioned they have pneumonia and recovery from the surgery.The patient asked if there was a difference between fentanyl and super fentanyl.Agent reviewed information and recommend patient consult with healthcare provider for next steps.
Additional Manufacturer Narrative
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 patient with an implantable pump.It was reported that the reason for the call was they needed assistance with the 90% lag issue again.The agent had a very difficult time keeping the patient focused throughout the call and the patient was talking very fast.The agent reviewed information and assisted the patient with clearing the data.The patient stated they hated the communicator and the handset and the old personal therapy manager (ptm) was so much better.The agent reviewed best practices for external devices and the patient would monitor the issues.When asked how many times per day the patient bolused - the patient stated 10 because the pain fluctuated but lately, they hadn't been using a whole lot and they were going back next month to have it re-done.The patient stated they normally did 3 boluses depending on the pain.The patient also stated that they did not put the refill date in correctly, the patient stated they see (b)(6) 2025 as the refill date.The patient also commented that they had not been using boluses due to these equipment issues.The patient stated sometimes they were in a lot of pain and they didn't get the results like they were used to but, they did feel better when they bolused.The patient stated they stayed in bed 90% of the time.The patient was redirected to health care provider (hcp) to further address refill date.

• 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: 22795401
• Report Number: 3004209178-2025-13742
• Device Sequence Number: 15650730
• Product Code: LKK
• UDI-Device Identifier: 00643169984219
• UDI-Public: (01)00643169984219(17)200128
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 10/08/2025

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: 01/28/2020
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/08/2025
• Date Device Manufactured: 07/31/2018
• 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: 62 YR
• Patient Sex: Female