MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number	B35200
Medical Device Problem Codes	Break (1069); Low impedance (2285)
Health Effect - Clinical Code	Adhesion(s) (1695)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had visible tension/bowstringing in the neck from the extensions.Surgery performed today to relieve the tension and it was found there was a low impedance of 72 ohms between contacts 1 and 2 of the left lead.Surgeon elected to replace both extensions due to impedance and bowstringing.Surgeon said the bowstringing was due to scar tissue and not from the extension cables being too short.Old extensions were removed and replaced with new legacy extensions.The battery was also replaced due to normal battery depletion.Issues have been resolved.
Additional Manufacturer Narrative
B3: event date is not known.Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id 3708660 (serial: (b)(6)); product type: 0191-extension; implant date (b)(6) 2012; explant date (b)(6) 2025 brand name activa; product id 3708660 (serial: (b)(6)); product type: 0191-extension; implant date (b)(6) 2012; explant date (b)(6) 2025.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.
Additional Manufacturer Narrative
D10: section d information references the main component of the system and other applicable components are the extensions.Product id 3708660, serial# (b)(6), implanted: (b)(6) 2012.Explanted: (b)(6) 2025, product type: extension.Product id 3708660, serial# (b)(6), implanted: (b)(6) 2012, explanted: (b)(6) 2025, product type: extension.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
Additional information was received from a manufacturer representative (rep).The rep reported that the surgeon said it was a problem with the extensions.Surgeon said he thinks the extension was damaged, possibly due to the tightness/bowstringing that was seen.Issue is resolved.

• Brand Name: PERCEPT
• Common Device Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 23450845
• Report Number: 3004209178-2025-18666
• Device Sequence Number: 9040815
• Product Code: MRU
• UDI-Device Identifier: 00763000420987
• UDI-Public: (01)00763000420987(17)221214
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 12/14/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 12/17/2020
• 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...."; SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female