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

Model Number	8637-40
Medical Device Problem Codes	Filling Problem (1233); Material Integrity Problem (2978); Positioning Problem (3009)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
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 receiving dilaudid (hydromorphone) (7.5 mg/ml at 4.1017 mg/day) and bupivacaine (5 mg/ml at 2.7345 mg/day) via an implantable pump for unknown indications for use.It was reported that the patient's pump was sitting in the abdomen in an oblique position which made refills challenging.Additionally, the catheter tip was found at t8 based on previous imaging, so the healthcare provider (hcp) was planning to pull the catheter down through the pump pocket to t10 to see if it would provide the patient (pt) better pain relief.The pt was taken to the operating room today for a planned pocket revision.The hcp began by opening up the pump pocket and dissecting down to the existing pump and proximal segment.The hcp removed the existing pump from the pocket and placed it on the sterile table.After disconnecting the pump, the hcp proceeded to dissect out the full length of the proximal segment.Hcp then disconnected the proximal segment from the spinal segment at the collet.They noted cerebrospinal fluid (csf) freely dripping from the spinal segment.Under fluoroscopic guidance, the hcp attempted to pull the catheter down from t8 to t10.While putting traction on the catheter, the spinal segment broke and retracted back into the subcutaneous tissue.The hcp decided to fully replace the catheter.The pt was repositioned into a lateral decubitus position.The hcp opened up the midline lumbar incision.A new catheter was placed at posterior t10.After the new catheter was anchored and tunneled to the existing pump pocket, the hcp attached the new proximal segment, and then the existing pump.Catheter aspiration was done with positive return of csf.The pump was placed back within the existing pocket and anchored.Incisions were irrigated and closed.The hcp was cautioned that the broken spinal segment had freely dripping csf at the start of the case, but the hcp opted to abandon that catheter without further intervention.A suspected contributory factor was body habitus as the pt's bmi was around 58.The issue was noted to be resolved at the time of the report.
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.Section d information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(6), implanted: (b)(6) 2019, explanted: (b)(6) 2026, ubd: 29-aug-2018, 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: 50483249
• Report Number: 3004209178-2026-14577
• Device Sequence Number: 13285251
• Product Code: LKK
• UDI-Device Identifier: 00763000422615
• UDI-Public: (01)00763000422615(17)231228
• 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: 2022
• 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): 08/27/2026

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: 12/28/2023
• 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: 08/13/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 07/08/2022
• 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: Female