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

Model Number	37612
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Collision (1429)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient fell and broke their neck the other day and is in a hospital and needs to do an mri before they can do surgery.Caller said that the folks at the hospital are confused about what to do in terms of getting the physical examination of the device and wires and the batteries before they go in the mri machine.Caller asked if there is a local manufacturer representative (rep) that can do the mri.Reviewed mri guidelines and redirected caller to patient's managing healthcare provider to further address the issue.When asked, caller said that patient's neurologist is at the clinic, which is about 2 hours away from the hospital and the primary neurologist isn't able to inspect the device herself.Caller said that they were directed to contact someone locally to assist.Caller also said that they just got back from an x-ray and the mri facility said they won't do the scan unless some verification is provided.Caller wanted to know about the mri eligibility form.After consulting with technical services and reviewed information.Email was sent to field staff to notify them of the situation and request that they follow up with the patient rep and the hospital." caller also mentioned something that the wire might be out of place due to the fall and neck injury.
Additional Manufacturer Narrative
Continuation of d10: product id: 3708660; lot#serial#: (b)(6); implanted: on (b)(6) 2014; product type: extension.Section d information references the main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot#: (b)(6), ubd: 08-aug-2018, 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: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 25396355
• Report Number: 3004209178-2026-09523
• Device Sequence Number: 10718295
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: (01)00643169864238(17)200914
• 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: 2020
• 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): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/04/2026
• Date Device Manufactured: 10/23/2019
• 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."
• Patient Age: 71 YR
• Patient Sex: Female