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

Model Number	8637-40
Medical Device Problem Codes	Improper Flow or Infusion (2954); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Health Effect - Clinical Code	Pain (1994)
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) via an implantable pump for unknown indications for use.It was reported that for the last several months she has had increased pain.She also states that at her last three routine pump refill visits she had volume discrepancies.She is unable to provide the exact expected/actual volumes, nor does she remember the exact dates.She states that she also had a dose increase that she did not notice any benefit from.On (b)(6) 2026, she had a catheter access study performed by the managing provider which she reports was negative.Patient denies any falls, recent surgeries, or other precipitating factors. patient was taken to the or today for a planned catheter revision.The physician began by opening up the existing pump pocket and dissecting down to the existing pump and proximal segment.He attempted to aspirate from the catheter access port, but had no return of csf.He then cut approximately 10 cm off of the proximal segment, and attempted to aspirate directly from the remaining catheter, but still had no return of csf.At this time, the physician proceeded to open up the midline lumbar incision and dissected down to a previously existing anchor.He removed the collet from the midline incision and cut it proximal to the spinal segment, and again attempted to aspirate directly from the spinal segment, but still had no return of csf.At this point, he attempted to put some tension on the catheter to pull it down within the intrathecal space, but the catheter broke and retracted back into the tissue.At this point, the physician opted to replace the catheter in it¿s entirety.  he then anchored the new catheter and tunneled it to the existing pump pocket and connected it to the new collet and new pump.Another catheter aspiration was performed before and after replacing the pump back within the existing pump pocket.Incisions were then irrigated and closed.There were no allegations regarding the previously existing pump.The cause of the catheter obstruction was not determined and the issue was resolved.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name ascenda; product id 8781 (serial: (b)(6)); product type: 0184-catheter; implant date (b)(6) 2015; explant date (b)(6) 2026.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: 50758016
• Report Number: 3004209178-2026-15519
• Device Sequence Number: 9333415
• Product Code: LKK
• UDI-Device Identifier: 00763000422615
• 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: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 01/14/2023
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 07/27/2021
• 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
• Patient Weight: 174 LB