MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number	37612
Medical Device Problem Codes	Failure to Deliver Energy (1211); Delayed Charge Time (2586); Battery Problem (2885); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Numbness (2415); Shaking/Tremors (2515); Insufficient Information (4580)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that yesterday, the patient's therapy unexpectedly shut off.They felt numb on the side of their face and started shaking.They got the recharger and spent a lot of time charging because it was difficult to get connected to recharge.So they went to the hospital/emergency room (er) to get things checked out and due to increased tremor.The patient was hospitalized due to lack of charge.They were told that they did not think it was too low.However, it was also noted that the patient's battery ran out of charge.Once they discovered it was off, they turned it back on.The patient noticed sensation when it was off and back on.The sensation went away and this has happened to them in the past 3 times where they felt that sensation.They wanted to prevent therapy turning off in the future and provided product suggestion.The potential for therapy to turn off if the ins battery got too low was reviewed.The patient stated that they do not let the battery get low.They charge 3 times a week for an hour or more.They recently have not been checking because the equipment all needs to get plugged in and they have a lot of things to plug in.During the call, the patient used the recharger app and recharger and was successful to start charging.Their ins battery was 100% and they had an excellent connection.Patient compliance may have led or contributed to the issue as they do not check if the device needs to be charged and just does it every 2-3 days.In addition, they had seen a provider about a month before and were told that if any of the settings have been adjusted or increased, this may have caused the early depletion if not paying attention to when it actually needs to be charged.The device was now back in proper working order and the patient was going to manage and keep an eye on it.The issue was resolved.
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: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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 ; +1(763)526-5677
• MDR Report Key: 50082450
• Report Number: 3004209178-2026-12548
• Device Sequence Number: 10753733
• Product Code: PJS
• UDI-Device Identifier: 00763000519247
• UDI-Public: (01)00763000519247(17)231028
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 12/05/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female