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

Model Number 37612

Device Problems Break (1069); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Malaise (2359); Electric Shock (2554)

Event Date 04/08/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 3389s-40, lot# va0vvkr, implanted: (b)(6) 2015.Product type lead.Section d information references the main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(6), ubd: 08-apr-2018, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding an implantable neurostimulator (ins).The patient reported that for the past 6-8 months their parkinson's has gotten so bad and they have not been doing well.The patient added that their brain was "going alzheimer's or something." yesterday, the patient went to their managing healthcare provider (hcp) to have their dbs checked because it seemed like it wasn't doing what it was supposed to be doing.One thing the hcp discovered was that the ins was turned off, which the patient thought was weird.The hcp turned the ins on, but then the patient felt a painful shocking sensation which they likened to sticking their finger in an outlet.The patient said the shocking sensation has been constant, but more so when they move their head one way.Then, the hcp did some "x-rays and stuff" and told the patient that an implanted wire was broken and kinked (the patient thought ht they heard the hcp say the word "lead").Agent asked the patient if they had any falls or trauma that could have led to the issue, but the patient said no.The patient did not do any excessive bending, twisting, or stretching prior to this event.The patient said they will be following up with their hcp to determine if they need to do surgery to repair the implanted wire that was broken/kinked.The patient was redirected to their hcp to further address the issue.

• Brand Name: ACTIVA
• Type of Device: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18439485
• MDR Text Key: 331904565
• Report Number: 3004209178-2024-00141
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2023
• Date Device Manufactured: 06/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male