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

Model Number	97755
Medical Device Problem Codes	Failure to Interrogate (1332); Overheating of Device (1437); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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
Information was received from a patient (pt) regarding an external device.The reason for call was patient reported issues with charging their implant.Patient stated that the new controller had not resolved the problem and that they experienced more errors.Patient described that at times the device displayed messages such as "unable to locate device" and "system problem rm03." they explained that they had to remove the battery, blow air on the port, and wipe the pins in order to continue use.Patient also reported that the recharger feels warm while charging the implant.Agent had the patient to reset the controller.Patient did not have ac power cord or recharger available for troubleshooting.Patient believed issue was with battery pack or controller.Agent reviewed rm03 error message with patient; patient requested replacement of all devices; agent advised patient that serial numbers and troubleshooting were required to verify which equipment needed replacement.Patient abruptly disconnected the call.Pt called back and reiterated details of case.Pt mentioned they had the controller replaced in the past and "that did not seem to help." pt said they still got rm03.Pt mentioned they had the controller charged at 40% and tried to charge ins, but when they tried to charge the ins, they could not get the ins to charge and the controller ran out of charge before they could get the ins charged.Pt was frustrated on the call and said they were "going to die" without the stimulator.Agent asked the pt to plug the controller into the ac power supply without li battery pack installed, but pt said they did not have the recharger or ac power supply with them.Agent requested the pt call back for further troubleshooting once they have all equipment with them.Pt said the li battery pack was the issue because they tried "on two different stimulators." pt got frustrated and disconnected call.
Additional Manufacturer Narrative
2026-mar-23: correction.Pli 30 should of been system reported through the implant.See report 3004209178-2026-05187.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.
Additional Manufacturer Narrative
Analysis of the [recharger], model [97755], s/n (b)(6), revealed.Analysis found"no device found" 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: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 24560634
• Report Number: 3004209178-2026-04325
• Device Sequence Number: 9593709
• Product Code: LGW
• UDI-Device Identifier: 00763000372095
• UDI-Public: (01)00763000372095(11)210211
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 97755
• Device Catalogue Number: 97755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 04/24/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/23/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1535-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11....".; "SEE H11....".
• Patient Sex: Female