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

Model Number	37603
Medical Device Problem Codes	Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Vertigo (2134); Twitching (2172); Shaking/Tremors (2515); Electric Shock (2554)
Date of Event	06/20/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the patient's implantable neurostimulator was not working for almost 7 years, failing to alleviate the patient's tremors.The patient experienced side effects, including twitching in the face and affected the mouth's right side.Additionally, for the past 8-9 months or longer, they have occasionally felt a twinge of a shock when lying down on the left side, where the implant is located.When asked, patient said has vertigo and falls a lot.They were advised to consult their healthcare provider and to schedule an appointment to have the implanted system checked.Patient stated the system hasn't ever been checked other than during reprogramming appointments.When offered to check listings, patient declined.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received from the consumer reported the device worked, but they were unable to successfully program to where the device controlled their tremors without side effects.The patient mentioned in the last year and a half on rare occasion they would experience a tiny shocking sensation when their laid on their left side and asked if this could mean their battery was leaking.The patient mentioned they hadfallen, but nothing that would damage the device.

• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20844832
• Report Number: 3004209178-2024-23031
• Device Sequence Number: 19775753
• Product Code: PJS
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• 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,Followup
• Report Date (Section B): 01/23/2025

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: 11/28/2016
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/23/2025
• Date Device Manufactured: 06/01/2015
• 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
• Patient Age: 67 YR
• Patient Sex: Female