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

Model Number	8637-40
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient who was receiving dilaudid (hydromorphone) via an implantable pump for non-malignant pain.It was reported that in (b)(6) they had a pump refill, and they had an opioid crisis after the refill.They stated within 15 minutes, they felt like they had iv of morphine.The patient stated the managing healthcare provider (hcp) did an audit, and there was medication missing.They then stated at the next refill, which was (b)(6), they had another opioid crisis but not as bad as (b)(6).They mentioned they tried to do a dye study, and they could not get anything from the catheter withdrawn so they could inject the dye.The agent reviewed information.The patient was redirected to their healthcare provider to further address the issue.
Additional Manufacturer Narrative
Continuation of d10: product id: 8780, serial# (b)(6), implanted: (b)(6) 2022, product type: catheter.Section d information references the main component of the system.Other relevant device(s) are product id: 8780, serial/lot #: (b)(6), ubd: 09-sep-2024, udi#: (b)(4).B3: event date is year valid.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 ; +1(763)526-5677
• MDR Report Key: 50789861
• Report Number: 3004209178-2026-15680
• Device Sequence Number: 10510395
• Product Code: LKK
• UDI-Device Identifier: 00763000634100
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/16/2026

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: 02/28/2024
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 09/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Patient Age: 37 YR
• Patient Sex: Female