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

Model Number	37714
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
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 since today, they were having a hard time charging their implantable neurostimulator (ins) and controller.Patient stated that the controller battery was at 60% and the ins at 50% but when they attempt to charge the ins it would say poor recharge quality or terminated and when they connected the controller to the ac power supply it would not blink green.Patient also mentioned during the call that the controller showed a battery low recharge controller message but the battery on the controller was still at 60%.Agent walked patient through resetting the controller using the ac power supply.Patient confirmed the controller powered on.Patient confirmed the controller was recharging.Patient also inspected for damages and saw no damages on the battery pack, controller compartment, and recharger.Patient attempted to start a charging session, and the controller was stuck at the checking recharge quality screen until the controller went to sleep.Patient attempted to unlock the controller, and it started charging the ins with excellent quality.After a few moments without the patient moving, the controller showed a poor recharge quality message.The issue was not resolved.A request was sent to repair to replace the recharger.Patient mentioned having the ins replaced before because they started to experience charging the ins twice a day, and they were told by their healthcare provider (hcp) that it was due for a replacement.
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 since today, they were having a hard time charging their ins and controller.Patient stated that the controller battery was at 60% and the ins at 50% but when they attempt to charge the ins it would say poor recharge quality or terminated and when they connected the controller to the ac power supply it would not blink green.Patient also mentioned during the call that the controller showed a battery low recharge controller message but the battery on the controller was still at 60%.Agent walked patient through resetting the controller using the ac power supply.Patient confirmed the controller powered on.Patient confirmed the controller was recharging.Patient also inspected for damages and saw no damages on the battery pack, controller compartment, and recharger.Patient attempted to start a charging session, and the controller was stuck at the checking recharge quality screen until the controller went to sleep.Patient attempted to unlock the controller, and it started charging the ins with excellent quality.After a few moments without the patient moving, the controller showed a poor recharge quality message.The issue was not resolved.A request was sent to repair to replace the recharger.Patient mentioned having the ins replaced before because they started to experience charging the ins twice a day, and they were told by their hcp that it was due for a replacement.

• Brand Name: RESTORE SENSOR
• 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: 23093061
• Report Number: 3004209178-2025-15876
• Device Sequence Number: 15873305
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: (01)00613994610430(17)160514
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2016
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 09/19/2025
• Date Device Manufactured: 06/16/2015
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female