MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ASCENDA; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8780
Medical Device Problem Codes	Obstruction of Flow (2423); Failure to Disconnect (2541); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Positioning Problem (3009)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Insufficient Information (4580)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id 8637-40 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: product type pump section d information references the main component of the system.Other relevant device(s) are: product id: 8637-40, serial/lot #: (b)(6), ubd: 28-sep-2020, 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
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiv ing fentanyl (1500 mcg/day at 271.7 mcg/day) via an implantable pump.It was reported that a catheter access study was done in (b)(6) 2026 in preparation for prophylactic pump replacement due to eos.Unfortunately, he was unable to aspirate any csf from the catheter access port and the patient was subsequently scheduled for catheter revision with routine pump replacement.The catheter was found to be anchored to subcutaneous fat and not the fascia.The healthcare provider also reported calcium buildup within the pump pocket.Exact cause of catheter obstruction was unknown.During surgery the physician dissected out the full length of the proximal segment but did not note any csf from the catheter.He then proceeded to disconnect the proximal segment from the spinal segment at the collet.He attempted to aspirate directly from the spinal segment, but had no return of fluid.He then proceeded to flush preservative free normal saline through the catheter multiple times, cautioned about drug remaining in catheter, but still had no return of csf.He then proceeded to attempt to pull the catheter down under fluoroscopic guidance, but when he put traction on the catheter, the catheter broke and was pulled out through the pump pocket.

• Brand Name: ASCENDA
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 25432285
• Report Number: 3007566237-2026-00012
• Device Sequence Number: 10373679
• Product Code: LKK
• UDI-Device Identifier: 00613994555595
• UDI-Public: (01)00613994555595(17)141103
• 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: 2012
• 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): 06/08/2026

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: 11/03/2014
• Device Model Number: 8780
• Device Catalogue Number: 8780
• 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: 06/01/2026
• Initial Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 11/03/2012
• 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: 77 YR
• Patient Sex: Female