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

Model Number	37702
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pocket Erosion (2013); Unspecified Tissue Injury (4559)
Date of Event	12/13/2025
Type of Reportable Event	Malfunction
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Per caller, her grandmother has a spinal cord stimulator system and is currently in hospice care.As of last saturday (b)(6), the patient's (pt) ins came out of the ins pocket because the ins had eroded through the skin due the grandmother's declining health.Caller works with an hcp who is willing to write an order to have the leads cut by a nurse so that the wound can be dressed properly but the hcp is looking for the manufacturer to approve of this order.Tss reviewed that the manufacturer doesn't have any medical standing or resources to provide and that caller will need to depend on the nursing or other staff available to her to address the ins pocket wound and the concerns about infection that the caller had.Caller will try to contact a wound care specialist to see if they can assist with the situation as well.The caller mentioned that the pt's ins pocket wound had been open for a while but when asked, never offered a timeframe for what that meant.

• Brand Name: PRIMEADVANCED
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO JUNCOS; 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: 23963861
• Report Number: 3004209178-2026-00130
• Device Sequence Number: 4746406
• Product Code: LGW
• UDI-Device Identifier: 00613994842312
• UDI-Public: (01)00613994842312(17)140714
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: 07/14/2014
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 01/18/2013
• 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 Age: 87 YR
• Patient Sex: Female