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

Model Number	B35200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930); Pocket Erosion (2013); Shaking/Tremors (2515)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient has had a serious complication with their device.Caller mentioned patient had a non rechargeable device implanted about 18 months ago to replace a rechargeable device that they were having trouble with.Caller mentioned patient has dementia and got device for essential tremor.Caller mentioned patient has had implants replaced in the past.Caller reported they noticed a sore on patient's right chest wall kind of right by where the implant battery is (caller stated implant is subcutaneous placement).Caller stated it didn't look severe, but it was like a red blotch that became worse and worse.Caller clarified it was a red spot that looked like a little skin lesion and stated they thought maybe it was just a bruise or skin lesion or something that was noted on (b)(6).Caller stated patient had appointment with hcp, patient's "dementia person", then went to their movement disorder clinic to look at the skin lesion and their healthcare providers did not know what it was.Caller stated they watched it and the device broke through patient's skin so the doctor removed it due to potential for infections.Caller stated patient is currently inpatient at (b)(6) hospital.Caller stated patient is probably going to require additional care including pic lines to take care of potential for infections and stated this is a dramatic change in patient's level of wellness.Caller clarified that patient's implant was removed last thursday and the wednesday before that they removed the bandage that was over the skin lesion and then discovered what they initially thought to be "wiring showing up" but it turned out to be corner of the implant.Caller stated then the next day hcp looked at it with alarm and said it has to be removed immediately because of exposed cable and wiring in the back of patient's skull.Caller stated patient has high risk of infection now.Caller stated they know patient's essential tremor will likely come back.Caller stated patient's quality of life has not been good and patient will not be having any life saving measures.Caller mentioned patient has been living in a memory care unit and stated patient has been able to ambulate, feed them self, and has some mobility issues but has used a walker proficiently.Caller stated patient has been without any dbs for about 10 days now.Initially caller stated they were seeking medical assistance.Agent reviewed role of manufacturer and redirected caller to patient's healthcare provider to further discuss.Caller stated patient will need placement in skilled nursing facility eventually but will be in the hospital for the near term.Caller mentioned patient's dbs has been a blessing to patient for the last 15 years and allowed patient to do things they could not do before so caller stated they are not angry.Agent sent email to patient relations rep with request to contact caller per caller's request.
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.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: 50057640
• Report Number: 3004209178-2026-12551
• Device Sequence Number: 16135154
• Product Code: PJS
• UDI-Device Identifier: 00763000916268
• UDI-Public: (01)00763000916268(17)260714
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2026
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 07/15/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female