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

Model Number	8637-20
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding an implanted infusion pump.It was reported that the rep requested a calculation in a catheter revision case.They were needing to dilute the medication since the catheter was found to be broken.
Additional Manufacturer Narrative
Continuation of d10: product id: neu_unknown_cath; serial# unknown.Product type: catheter.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_cath, 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.
Additional Manufacturer Narrative
Continuation of d10: product id: 8709sc, serial# (b)(6), implanted: (b)(6) 2012, explanted: (b)(6) 2025, product type: catheter.Section d information references the main component of the system.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(6), ubd: 2013-07-14, 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.
Event or Problem Description
Additional information was received from a healthcare provider (hcp) via a manufacturer's representative (rep) regarding the patient receiving morphine (.2502mg/day at 4.5mg/ml) via an implantable infusion pump for non-malignant pain.It was reported that during a pump replacement, the catheter was found to be broken so the hcp opted to replace it with a new one.The hcp asked the rep to calculate a dilution to the medication so the rep contacted technical services but the hcp went through the math with the rep and they resolved it on their own.There were no issues, signs, or symptoms, and no environmental, external, or patient factors known to have contributed to the event.No diagnostics or troubleshooting were performed, as the hcp visually identified the break in the catheter.The catheter was replaced with a new one, the broken catheter was discarded, and the hcp assisted the rep with the calculation and new tablet settings.The issue was resolved at the time of this report.

• 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 MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23742829
• Report Number: 2182207-2025-03344
• Device Sequence Number: 18694214
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: (01)00643169530119(17)191228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: 12/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 07/12/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male