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

Model Number	37603
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Codes	Dysphasia (2195); Shaking/Tremors (2515)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reports their patient programmer is not working correctly. screen shows a computer code like a paragraph of letter and numbers.Patient mentioned that over the years, settings have been optimized so that their tremors are somewhat under control but her spe ech is not overly affected.Recently, patient had a complication of osteonecrosis of the jaw.In order to treat the infection that is causing it, they prescribed the antibiotic doxycycline and after about a week of taking it, their tremors are out of control.Patient isn't sure if antibiotic is causing worse tremors.About 3 days ago, patient used the programmer to check the implantable neurostimulator (ins) and it was indicating the normal settings.Patient waited a few days to see if the tremors got better and they didn't.Yesterday, patient wanted to make some adjustments to the settings but the patient programmer display was blank even though they replaced the aaa batteries.The display remained blank but device did beep.Patient rep called back and mentioned that when they increased dbs settings, it caused patient's speech to not be as good (slurred).Rep said they will follow up with the patient's neurologist to analyze the patient's tremor and determine if the therapy settings need to be changed. patient services emailed repair to replace programmer.2024-05-09 rtg0556067 update (con): no new information.
Additional Manufacturer Narrative
Section d10 references: product id 37642 lot# serial# (b)(6) product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 37642, serial/lot #: (b)(6), udi#: (b)(4) h3.Analysis of the patient programmer (s/n (b)(6)) found the device wouldn¿t power on even when plugged in.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 ESSENTI
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19604591
• Report Number: 3004209178-2024-13350
• Device Sequence Number: 7392515
• Product Code: PJS
• UDI-Device Identifier: 00763000100353
• UDI-Public: 00763000100353
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/24/2024

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: 02/14/2022
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2020
• 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 Sex: Female