MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ACTIVA; implanted subcortical electrical Stimulator (motor disorders)

Model Number	3708660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Hypersensitivity/Allergic reaction (1907); Anaphylactoid / Anaphylaxis (2218); Insufficient Information (4580)
Date of Event	01/08/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient wanted to know if any of the implanted components contain nickel as they have a severe nickel allergy.Agent reviewed that the implantable neurostimulator (ins) does not contain nickel.Agent reviewed that one of the extension materials (stainless steel) contains nickel that only makes contact with the body during the implant procedure.Agent reviewed that one of the lead materials (mp35n) contains nickel that contacts human tissue.It was at this point that the patient reported that they have had severe migraines ever since the leads were implanted.The patient stated that they have had spontaneous anaphylactic reactions and massive mast cell issues that have gotten increasingly worse since the leads were implanted.The patient stated that they have been completely disabled since the leads were implanted because of the migraines, and they had to stop working.The patient stat ed that their whole health declined and they have other health issues as well that they think might be related to this event.The patient noted that their health issues have completely ruined their life and alleged that the nickel in the leads was responsible for their suffering.The patient mentioned that they have spoken with a lot of other dbs patients who got severe migraines after they were implanted, and they think those patients could potentially have a nickel allergy as well.The patient was very frustrated because their surgeon had assured them there was no nickel in any of the implanted components prior to implant date.The patient mentioned that at one point their managing hcp told them that explanting the leads could potentially cause brain damage due to how long the leads have been implanted.The patient asked what they should do about this situation.The patient was redirected to their healthcare provider to further address the issue.Additional information received from hcp indicating that cause of the reaction remains unknown, and resolution of this issue remains unknown.
Additional Manufacturer Narrative
Continuation of d10: product id: 3387s-40, lot# va0p406, implanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot# va0psrb, implanted: (b)(6) 2015, product type: lead.Product id: 3708660, lot# serial# (b)(6), implanted: (b)(6) 2015, product type: extension.Product id: 37612 lot# serial# (b)(6), implanted: (b)(6) 2019, product type: implantable neurostimulator.Section d information references the main component of the system.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(6), ubd: 22-jul-2017, udi#: (b)(4).Product id: 3387s-40, serial/lot #: (b)(6), ubd: 27-aug-2017, udi#: (b)(4) ; product id: 3708660, serial/lot #: (b)(6), ubd: 24-jul-2018, udi#:(b)(4).Product id: 37612, serial/lot #: (b)(6), ubd: 14-feb-2020, udi#: (b)(4).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: ACTIVA
• Common Device Name: implanted subcortical electrical Stimulator (motor disorders)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23728773
• Report Number: 2649622-2025-34047
• Device Sequence Number: 10216175
• Product Code: MRU
• UDI-Device Identifier: 00613994749116
• UDI-Public: (01)00613994749116(17)181105
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2018
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/05/2025
• Date Device Manufactured: 11/05/2014
• 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...."
• Outcome Attributed to Adverse Event: Disability; Other
• Patient Age: 29 YR
• Patient Sex: Female