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

Model Number	97702
Medical Device Problem Codes	Malposition of Device (2616); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date is approximate.Year is confirmed valid.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator (ins).The reason for the call was the patient reported they saw their pain management doctor on the 5th and the doctor thinks that their stimulator might not be working and that it is located in a bad place on their body.Patient reported that the doctor wants a representative to meet with the patient to check the ins.Patient noted their doctor was planning to call as well.Patient stated that the ins touches their spine and pinches their nerves in their lower back and has always been this way since it was implanted in 2015.Patient noted that their doctor told them to call and patient reported they called the representative multiple times, leaving a voicemail but they have not heard back.The patient was redirected to their healthcare provider to further address the issue.Agent provided the patient with the phone number for their doctor to call.

• Brand Name: SURESCAN
• 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: 25138171
• Report Number: 3004209178-2026-08034
• Device Sequence Number: 9779724
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: (01)00643169109513(17)161114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2016
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 05/26/2026; 06/18/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/17/2026; 06/30/2026
• Date Device Manufactured: 05/21/2015
• 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
• Patient Age: 45 YR
• Patient Sex: Female