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

Model Number	B35200
Medical Device Problem Codes	Premature Discharge of Battery (1057); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient's dbs system has not worked.Patient reported they were told the device would last longer and was smaller, but reported once it was in their chest it wasn't smaller dimensionally.Patient stated the only thing that is even kind of comfortable is laying on their side and it is extremely debilitating right now and reported their implant just died on them out of the blue on tuesday.Patient inquired if there is a way to expedite the surgery if their system just dies.Patient also inquired about implant longevity.Agent reviewed longevity overview and redirected patient to their doctor to discuss.Patient also expressed dissatisfaction with their healthcare provider as patient stated their hcp did not put the battery in the right place and his pa did not close up the site well.* see (b)(4)for symptoms on initial programming and rep dissatisfaction * see (b)(4) for historical device dissatisfaction.
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.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: 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: 25608953
• Report Number: 3004209178-2026-10631
• Device Sequence Number: 9972137
• Product Code: MRU
• UDI-Device Identifier: 00763000420987
• UDI-Public: (01)00763000420987(17)221128
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: 11/28/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 12/11/2020
• 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
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female