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

Model Number	97712
Medical Device Problem Codes	Failure to Interrogate (1332); Energy Output Problem (1431); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	03/07/2018
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
Additional information was received from the patient stating the device was inoperative for last 4 years.It didn't provide pain relief even from day 1 and the battery started to cause pain itself.They have a removal scheduled for (b)(6) 2026.
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 who was implanted with an implantable neurostimulator (ins).The reason for call was patient stated that their stimulator has been inoperative for the last 2.5-3 years.Patient stated that the battery died and would not respond to the recharger to take any charge at all and they couldn't adjust settings or do anything.Patient said that the device has provided virtually no help at all since day one and is probably one of the biggest medical mistakes they have ever made in their life.Patient mentioned that they have nothing good to say about the device and they don't know if the doctor messed up or if the device wasn't done right or if they went back for multiple reprogramming and it was like crap.Patient noted that it is just a hunk of metal sitting in them and if they could find out what medicare would pay to have it removed and move on.The patient was redirected to their healthcare provider to further address the issue.Patient will have spinal cord stimulator removed.

• 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: 24135270
• Report Number: 3004209178-2026-01028
• Device Sequence Number: 18727974
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: (01)00643169109506(17)180328
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P1005A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 03/28/2018
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 01/27/2026
• Date Device Manufactured: 05/09/2017
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male