MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EXTERNAL NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	9772501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received regarding an implantable device.It was reported that the patient (pt) complained of pain in the pacu but the doctor examined them and stated it was just procedural.The patient called the manufacturer representative (rep) the following night ((b)(6)), stated they were in extreme pain and had pressure from his shoulder blades to the back of his head and could barely move their neck.The pt had a thoracic lead placement at t8 and t9 for lumbar pain.The rep reached out to the physician and instructed the pt to call the on call doctor or go to the er.The pt went to the er the next morning ((b)(6)).Pt was admitted and asked by the on call doctor to turn the stim back on.The pt refused and wanted the leads removed.The following morning ((b)(6)) the leads were removed and discarded, and the physician in the room confirmed the pt had a csf leak.The wife of the pt filled in the rep on all details that day ((b)(6)), the rep was not present for any of these interactions.The pt was scheduled for a blood patch the next day ((b)(6)).The pt did not want to move forward to implant at that time since they were not able the tell the efficiency of the device due to the csf leak pressure and pain.The rep attached an image with the device information.
Additional Manufacturer Narrative
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 regarding an implantable device.It was reported that the patient (pt) complained of pain in the pacu but the doctor examined them and stated it was just procedural.The patient called the manufacturer representative (rep) the following night (11/28), stated they were in extreme pain and had pressure from his shoulder blades to the back of his head and could barely move their neck.The pt had a thoracic lead placement at t8 and t9 for lumbar pain.The rep reached out to the physician and instructed the pt to call the on call doctor or go to the er.The pt went to the er the next morning (11/29).Pt was admitted and asked by the on call doctor to turn the stim back on.The pt refused and wanted the leads removed.The following morning (11/30) the leads were removed and discarded, and the physician in the room confirmed the pt had a csf leak.The wife of the pt filled in the rep on all details that day (11/30), the rep was not present for any of these interactions.The pt was scheduled for a blood patch the next day (11/31).The pt did not want to move forward to implant at that time since they were not able the tell the efficiency of the device due to the csf leak pressure and pain.The rep attached an image with the device information.
Additional Manufacturer Narrative
Continuation of d10: product id 977d260 lot# va379gf045: product type screening device.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: EXTERNAL NEUROSTIMULATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; juncos
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; juncos
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23684222
• Report Number: 2182207-2025-03297
• Device Sequence Number: 9716010
• Product Code: LGW
• UDI-Device Identifier: 00763000586850
• UDI-Public: (01)00763000586850(17)270402
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9772501
• Device Catalogue Number: 9772501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/01/2025
• Date Device Manufactured: 10/15/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male