MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO JUNCOS SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97702
Medical Device Problem Codes	Failure to Interrogate (1332); Malposition of Device (2616); Battery Problem (2885); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.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 mri caller regarding an implantable neurostimulator.The reason for the call was the caller stated that the patient was at the clinic for an mri, but they were not able to connect to the implant with the patient programmer.Caller stated the patient quit getting therapy 7-8 years ago, somewhere between 2017 and 2019.Caller mentioned that they put new batteries in the programmer, but that did not resolve the issue.Ins is superficial.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider for mri considerations.A patient rep also called as the initial caller, but handed the phone to the patient after providing their name and birth date.The reason for the call was the patient wanted to gather information regarding their implanted devices so they could get an mri.Patient stated their ins battery had died about 10 years, after lasting for maybe 4-5 years.The patient was redirected to their healthcare provider to further address the issue.Patient reviewed implant data and provided mri stim tech phone number for patient to give to their hcp/mri technicians if they had further questions about safety/labeling.Patient mentioned their current hcp was going to retire soon.Agent redirected the patient to prs at the end of the call so they could fax the patient's information to the hospital and request an id card for the future.
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
Additional information was received from a patient (pt).It was reported that they used the device almost continuously for as long as the battery lasted.They really did not see that it helped at all when the battery died.They did not replace it.Additional information was received from a patient (pt).It was reported that they never saw any benefit.The battery went dead and there was no reason to fix it.No actions were taken/will be taken.The issue is not resolved and they may remove the device.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO JUNCOS; 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: 24688639
• Report Number: 3004209178-2026-05350
• Device Sequence Number: 10041956
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: (01)00643169109513(17)141228
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 12/28/2014
• Device Model Number: 97702
• Device Catalogue Number: 97702
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 07/01/2013
• 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
• Patient Sex: Male