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); No Device Output (1435); Battery Problem (2885); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/02/2015
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator.The reason for call was patient said that the implant has never helped their pain since it was put in.They said "it never even turned on once, and they put another one in but it never turned on and it never connected".Pt is in the er now because they fell at work and needs an mri and is requesting we fax the er to show them what the pt has implanted.Since pt is most likely in eos state by now, warm transferred patient to prs so they can have an implant sheet faxed over to hcp.
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
Patient stated that their device has never worked once.When asked to clarify they stated that it just didn¿t work and it didn¿t hold a charge.They also reiterated that it did not turn on.They explained that they took that implant out and changed it out with a new one and the newer one did not work as well.They are not going to have more surgery and will just live with stimulator in their body.Patient didn¿t explain what the cause of the issue was just that it didn¿t work for them.
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.

• 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: 24471939
• Report Number: 3004209178-2026-03599
• Device Sequence Number: 9506741
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 11/14/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 12/17/2014
• 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: 31 YR
• Patient Sex: Male