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

Model Number	37603
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Choking (2464)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that it was reported that the patient (pt) needed to go to the er this weekend because they think pt is having gallbladder and appendix issues and their smart programmer is lost or stolen and they may need to turn therapy off for surgery.It was also reported that the caller said patient (pt) has been going to a doctor out of state even though they live elsewhere because the doctor who put in their most current implantable neurostimulator ((b)(6)2023) installed their wiring all wrong.Caller said the wiring was choking the pt because it crisscrossed in the front of their neck and they were flown to have it taken out and redone.Redirected to their doctor.
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(6), ubd: 17-mar-2021, udi#: (b)(4) ; product id: 3708660, serial/lot #: (b)(6), ubd: 17-mar-2021, 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 (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 ; +1(763)526-5677
• MDR Report Key: 50084107
• Report Number: 3004209178-2026-12774
• Device Sequence Number: 10753298
• Product Code: MRU
• UDI-Device Identifier: 00643169864214
• UDI-Public: (01)00643169864214(17)210228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 07/30/2026

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: 02/28/2021
• Device Model Number: 37603
• Device Catalogue Number: 37603
• 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: 07/20/2026
• Initial Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 09/10/2019
• 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...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female