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

Model Number	977006
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Codes	Numbness (2415); Ambulation or Postural Difficulties (2544)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient regarding an external device.The reason for call was patient said they hadn't used the communicator in maybe 5-4 years, but they thought they would try it again.Patient went to see the medtronic representative at the hospital a couple days ago and the representative couldn't get the tm91 to turn on.Patient said the representative said the implant was at 60% but the communicators wouldn't turn on at all.Patient also said the intensity was a little too much for him right now, his legs and feet were practically numb and it was hard to walk.Patient mentioned that they walk like they are half drunk when they get off balance.During the call, the communicator wouldn't power on.The issue was not resolved through troubleshooting.An email was sent to the repair department.Patient was redirected to healthcare provider to further address the issue.
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.

• Brand Name: VANTA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 25255609
• Report Number: 3004209178-2026-08799
• Device Sequence Number: 10511579
• Product Code: LGW
• UDI-Device Identifier: 00763000411923
• UDI-Public: (01)00763000411923(17)240714
• Combination Product (Y/N): N
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: 07/14/2024
• Device Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 07/20/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown