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

Model Number	37603
Medical Device Problem Codes	Battery Problem (2885); Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Codes	Fall (1848); Dysphasia (2195); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)
Date of Event	11/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient's symptoms have become more profound over the past year, including frequent falls, confusion, sleep disturbances, and speech difficulties.Additionally, the non-rechargeable implantable neurostimulator was not depleting as expected.The patient was redirected to their healthcare provider to further address these issues.Additional information was received from the consumer who reported the patient¿s non-rechargeable implantable neurostimulator (ins) had not shown any drop at all in the voltage since the patient got the rechargeable implant which was pretty unusual.The consumer stated somehow the rechargeable implant was interfering with it with the possibility they couldn¿t tell if the battery was actually depleting due to electromagnetic interference with the "read out".The consumer stated it was odd for two years not to have implant drop at all.It was noted the patient was falling a lot.The patient recently saw the physician who checked the implant which showed the battery hadn¿t depleted with their previous non-rechargeable implants not having this issue (they didn¿t think the therapy settings were any different either).The consu mer mentioned the patient couldn¿t have the battery replaced due to it¿s battery level not being at a certain percentage.
Additional Manufacturer Narrative
Section d10 references: product id 37612 lot# serial# (b)(6) implanted: (b)(6) 2022 product type implantable neurost imulator.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: 21053605
• Report Number: 3004209178-2025-00011
• Device Sequence Number: 18129605
• Product Code: MHY
• UDI-Device Identifier: 00763000100353
• UDI-Public: 00763000100353
• 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: 2021
• 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): 01/02/2025

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: 01/14/2022
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/02/2025
• Date Device Manufactured: 07/27/2020
• 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
• Patient Age: 67 YR
• Patient Sex: Male