MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO.; STIMULATOR, TIBIAL, ELECTRICAL, IMPLANTABLE, FOR URINARY INCONTINENCE

Model Number	P7850N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	06/03/2026
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.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) for unknown indications for use.It was reported that they had pain and swelling at the implant site since implant on (b)(6) 2026 but the swelling would improve when they would elevate their legs.The symptoms got worse around 3 days after implant and it was extremely painful to walk and patient had to use a crutch or a cane.Patient was currently at the er and the er doctor said the implant site was infected because it was red and swollen but they were doing further bloodwork to confirm.Patient services (pss) recommended patient follow up with managing healthcare provider (hcp) when they are able.Patient also requested that manufacturer field staff be made aware of the infection and an email communication was sent.

• Common Device Name: STIMULATOR, TIBIAL, ELECTRICAL, IMPLANTABLE, FOR URINARY INCONTINENCE
• 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: 25509401
• Report Number: 3004209178-2026-10054
• Device Sequence Number: 18768357
• Product Code: QPT
• UDI-Device Identifier: 00763000936433
• UDI-Public: (01)00763000936433(17)270528(20)01
• Combination Product (Y/N): N
• PMA/510(K) Number: P240011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: P7850N
• Device Catalogue Number: P7850N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 12/02/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female