MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	37702
Medical Device Problem Codes	Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Battery Problem (2885)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
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
Information was received from a patient who was implanted with an implantable neurostimulator (ins).The patient reported they hadn't used their therapy in probably 2 years due to not needing the therapy.The patient reported they turned therapy on today because they were having some back and sciatic nerve pain recently; however, the patient stated the therapy was not working very well, and they can barely feel any stimulation at all.The patient called their previous manufacturer representative (rep), who stated they were no longer with the manufacturer and gave the patient phone numbers for 2 current representatives.The patient called those numbers, but did not leave voicemails.The agent reviewed role of rep, and the patient was redirected to their healthcare provider to further address the issue.
Additional Manufacturer Narrative
Continuation of d10: product id 3888-28 lot# *unkser implanted: (b)(6) 1994 product type lead 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
Additional information was received from a patient.Lead migration was reported.The battery was depleted, and there was zero stimulation.The patient had an x-ray of the lead wires.The internal nonrechargeable implant battery and system were dead.The issue was not resolved.A system replacement was planned.

• Brand Name: PRIMEADVANCED
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 21621275
• Report Number: 3004209178-2025-04692
• Device Sequence Number: 6828461
• Product Code: LGW
• UDI-Device Identifier: 00613994842312
• UDI-Public: 00613994842312
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 10/28/2014
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/19/2025
• Date Device Manufactured: 05/06/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 98 KG