MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	37702
Medical Device Problem Codes	Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event is unknown, see b5 narrative for context surrounding date of event.Continuation of d10: product id 3998 serial# (b)(6) implanted: (b)(6) 2000: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3998, serial/lot #: (b)(6), 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 regarding an implantable neurostimulator (ins).The reason for call was patient reported that the stimulation was on but was not doing anything for them.Patient stated there was a spike in the stimulation that showed that it was supposed to be working but it was not.Patient commented one of the wire was off already, someone came to their health care provider's office to make an adjustment so they can feel the stimulation.Patient said that now the stimulation wasn't working at all and it was showing on their hand control that it should be firing up.Agent asked the patient when the issue started and patient said that they told the guy that was out last time that they used the stimulation sparingly because they didn't want to have another surgery to get another one put in but now something was wrong.Patient denied any recent falls/trauma.Agent instructed patient to increase stimulation, patient was able to increase stimulation but mentioned they can't feel the stimulation.Agent reviewed role of m anufacturer representative (rep) and provided patient with the national answering service number for hcp to use.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue. .
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 he is getting knee replacement and need someone to check the implant because the implant is on when the pp is showing implant is off.Patient stated the implant is not working.

• Brand Name: PRIMEADVANCED
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinnea road; ceiba norte industrial park; memphis,tn PR 00777
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinnea road; ceiba norte industrial park; memphis,tn PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22391194
• Report Number: 3004209178-2025-11339
• Device Sequence Number: 18431846
• Product Code: LGW
• UDI-Device Identifier: 00613994842312
• UDI-Public: (01)00613994842312(17)150514
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 05/14/2015
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/25/2025
• Date Device Manufactured: 11/20/2013
• 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