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

Model Number	977006
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Itching Sensation (1943); Pain (1994); Numbness (2415); Electric Shock (2554); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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
It was reported that a patient with an implantable neurostimulator stated they were experiencing shocks throughout the legs, mostly on the right side, during stimulation, along with severe itching on the right side, numbness of the whole right side after sitting more than 15 minutes, increased pain attributed to the implant, and a current bladder problem.The patient stated they had been having issues with the scs device since day 1 and expressed intent to have the implant removed.The patient also reported external device issues, including a communicator that would not power up (no light when the power button was pressed), a handset not being fully charged as expected, and inability of external devices to connect to the scs device despite having two sets of external devices.The patient reported that stimulation had been adjusted at a prior visit, but shocks persisted, and the patient needed therapy turned off for an upcoming surgery.During one call, the patient refused troubleshooting and disconnected the call.During a subsequent call, the agent walked the patient through connecting to the mystim application, and the patient successfully connected and turned therapy off, after which the patient was redirected to a healthcare provider for further evaluation.

• 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: 25803914
• Report Number: 3004209178-2026-11689
• Device Sequence Number: 9054289
• Product Code: LGW
• UDI-Device Identifier: 00763000849078
• UDI-Public: (01)00763000849078(17)260614
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2026

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: 06/14/2026
• 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: 06/23/2026
• Initial Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 06/14/2024
• 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