MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. Percept; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number	B35300
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pocket Erosion (2013); Scar Tissue (2060); Impaired Healing (2378)
Date of Event	09/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent surgery due to poor wound healing under lead/extension incision, which appeared to be red and scabbed.Patient still had scabbing and healing issues on the skin near the lead/extension connection block area from the original implant back in (b)(6) 2026.When the surgeon opened the original incision they found that the connection block had migrated directly under the incision causing wound erosion.Surgeon noted that the patients skin was already thin and somewhat difficult to close.The surgeon decided to place new extensions.The surgeon then made a pocket under the skin anterior to the incision to push the connection block away from the incision.The surgeon did not tie down the connection block to prevent it from migrating again under the incision though.The surgeon cut away the effected skin to properly close the incision.The incision was flushed out with a betadine solution, closed, and the patient was sent home with a round of antibiotics to prevent further infection.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name sensight; product id b3400060 (serial: va2vexbv65); product type: 0191-extension; implant date (b)(6) 2024; explant date (b)(6) 2026 brand name sensight; product id b3400060m (serial: va2vl0lv42); product type: 0191-extension; implant date (b)(6) 2024; explant date (b)(6) 2026 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: Percept
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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 ; +1(763)526-5677
• MDR Report Key: 50915262
• Report Number: 3004209178-2026-16394
• Device Sequence Number: 20175788
• Product Code: PJS
• UDI-Device Identifier: 00763000564346
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 12/14/2025
• Device Model Number: B35300
• Device Catalogue Number: B35300
• 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: 09/25/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 12/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 165 LB