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

Model Number	977006
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient (pt) regarding an external device.The reason for the call was to report that the pt was having issues connecting to the therapy app to turn their ins off.Caller stated that they were prompted to pair the communicator to their handset but was unable to successfully do so.Caller also explained that they were "zapped all night" because they were unable to turn stimulation off prior to going to sleep for the night.Agent attempted to walk the pt through troubleshooting but it seemed that the communicator wasn't charged.Agent instructed pt to charge the communicator, then call back for further assistance.Pt seemed confused with how the external equipment works.Pt kept commenting that the communicator was charged but was looking at the change level of the handset, not the communicator.Caller also added that they've been seeing eri for a while and have been approved to have their ins replaced.Pt said they have an upcoming appointment on (b)(6) 2026.
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: 25780713
• Report Number: 3004209178-2026-11569
• Device Sequence Number: 16140561
• Product Code: LGW
• UDI-Device Identifier: 00763000411923
• UDI-Public: (01)00763000411923(17)260128
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

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: 01/28/2026
• 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: 06/19/2026
• Initial Report FDA Received Date: 07/10/2026
• Date Device Manufactured: 02/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female