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

Model Number	8637-40
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
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 friend/family member regarding a patient who was receiving dilaudid (hydromorphone) via an implantable pump for intractable spasticity.It was reported that for 'about a week now, later stated 'maybe a week and a half ago,' the patient's pump had been alarming.The patient rep thought it was their personal phone at first, but then it went off again and they didn't even have their phone with them, so they were a little concerned about it.Agent asked if the alarm was a single tone or a dual tone, and caller stated it was probably single tone, but then stated 'it's like a ring tone on your phone.' it was noted the alarm went off 'it seems like sometimes it's every 20 minutes.' the patient's last refill was on (b)(6) at 10:30am.It was also reported the patient was having a lot of stomach problems.The caller mentioned the patient was susceptible to blood clots, and they were waiting on insurance approval to have a ct scan to see if the blood flow was flowing right, because the patient was susceptible to blood clots.The patient was told by the healthcare provider (hcp) they could not do anything due to waiting on insurance and told them to call medtronic.The agent assisted the caller in connecting to the pump using the 8835 ptm and saw a code of 8532.The agent consulted with pump technical services and the agent reviewed end of service (eos) and stop duration exceed tube set and redirected to the healthcare provider.While on the call, the patient came on the line and stated 'i've had over three pumps put in me, and i've been very happy with medtronic.I'm very sick right now, and it's taken forever to put in this one.It only took like a week with the previous ones.All these other pumps i've had put in, it was all done and now i'm trying to have this fourth one put in.It's taking so long".Additional information was received from a company representative (rep) on the date of this report and it was noted his pump was dead.There was nothing they could do but wait for the 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: 22811363
• Report Number: 3004209178-2025-13877
• Device Sequence Number: 15413244
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: (01)00643169530126(17)191214
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2019
• 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: 07/28/2025
• Initial Report FDA Received Date: 08/14/2025
• Date Device Manufactured: 06/22/2018
• 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
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male