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

Model Number	8637-40
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiv ing dilaudid (hydromorphone) (15 mg/ml at 0.104 mg/day) and bupivacaine (10 mg/ml at 0.069 mg/day) via an implantable pump for spinal pain indications.It was reported that a segment of the patient¿s previous 8780 catheter was cut, removed and discarded during a prior spinal fusion procedure.The length of the discarded segment is unknown.During the current catheter revision, the physician elected to replace only the spinal segment and estimated the length of the remaining catheter based on available measurements rather than replacing the entire catheter as recommended.The calculated catheter length of 108.8 cm was therefore not definitively confirmed.As a result, the exact length of the remaining catheter could not be established during the current revision. the patient was initially placed on minimum rate because the programmed drug concentration would otherwise have resulted in a higher initial dose.The new catheter was not primed because the patient had not been receiving medication prior to the revision.During the catheter revision procedure, a dye study was performed under fluoroscopy and confirmed that the remaining intrathecal catheter was functioning.The issue is resolved.
Additional Manufacturer Narrative
Continuation of d10: product id 8780 serial# (b)(6)implanted: (b)(6)2020 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: 02-nov-2022, udi#: (b)(4).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: 50841581
• Report Number: 3004209178-2026-15953
• Device Sequence Number: 21319547
• Product Code: LKK
• UDI-Device Identifier: 00763000634100
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 05/28/2025
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 12/06/2023
• 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...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female