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

Model Number	8782
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id 8780 (b)(6); product type: 0184-catheter; product id 8780 (b)(6); product type: 0184-catheter; implant date ; explant date product id 8782 (b)(6); product type: 0184-catheter; implant date ; explant date product id 8782 (b)(6); product type: 0184-catheter; implant date ; explant date product id 8786 (b)(6); product type: 0001-accessory; implant date n/a; explant date n/a 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 a healthcare provider via a manufacturer representative regarding catheters for an implantable intrathecal pump.It was reported that the physician was unable to thread the catheter cephalad; they kept wanted to go down instead of up.An external factor was that the physician was entering the intrathecal space without the use of live fluoroscopy at a 90 degree angle.The physician used spot checks intermittently instead of live fluoroscopy.The physician sheared the catheter.A spinal segment was given to the physician and the physician sheared the spinal segment, as well as the next two spinal segments given to them.The physician complained that the needle was "crappy" and became blunt/bent upon entry and asked for a new needle.The manufacturer representative gave the physician their last catheter and the same issue recurred with the inability to thread the catheter cephalad instead of down, and the last catheter was sheared.The case was aborted due to the inability to properly place the catheter and rescheduled for (b)(6) 2025.

• Brand Name: ASCENDA
• 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 ; 7635265677
• MDR Report Key: 22583416
• Report Number: 3004209178-2025-12583
• Device Sequence Number: 13134716
• Product Code: LKK
• UDI-Device Identifier: 00763000852610
• UDI-Public: (01)00763000852610(17)270602
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/23/2025

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 Model Number: 8782
• Device Catalogue Number: 8782
• 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: 07/10/2025
• Initial Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 06/02/2025
• 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: 84 YR
• Patient Sex: Female