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

Model Number	8637-20
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information was received from a healthcare provider via company representative who stated that the healthcare provider (hcp) was able to aspirate from the catheter but elected to replace it with an 8781 catheter.The hcp also decided to replace the pump.The cause of the possible underdose was not determined, nor was the reason for the unsuccessful dye study.No specific catheter malfunction was identified.
Event or Problem Description
Information was received from multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was receiving fentanyl (6.0 mg/ml at 4.4 mg/day) via an implantable pump for non-malignant pain indications for use.It was reported that thought the letter they received (see related event (b)(4)) was referring to their \"pump failure\" and the fact that they were not responding to the medication.Patient stated the therapy issue started \"several months ago.\" patient stated the healthcare provider (hcp) had done a catheter dye study and they couldn't tell where the medication was going.Patient stated the hcp planned a catheter revision.Additional information was received via a hcp through a manufacturer representative (rep) stating that they were concerned for possible underdose.There were no known external factors.The patient had their pump and catheter replaced.The issue was noted to be resolved.
Additional Manufacturer Narrative
Continuation of d10: product id 8596sc lot# serial# (b)(6) implanted: (b)(6)2009 explanted: (b)(6)2026 product type catheter product id 8709sc lot# serial# (b)(6) implanted: (b)(6)2009 explanted: (b)(6)2026 product type catheter.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
Section d information references the main component of the system.Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(6), implanted:(b)(6)2009, explanted:(b)(6)2026 ubd: 09-mar-2011, udi#: (b)(4) product id: 8709sc, serial/lot #: (b)(6), implanted:(b)(6)2009, explanted:(b)(6)2026, ubd: 19-mar-2011, 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: 50788483
• Report Number: 3004209178-2026-15665
• Device Sequence Number: 9570464
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• 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: 08/14/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• 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: 02/23/2022
• 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....\"
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male