MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number NEU_INS_STIMULATOR

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unauthorized Access to Computer System (3025)

Patient Problems Chest Pain (1776); Chills (2191); Numbness (2415); Diaphoresis (2452); Electric Shock (2554); Paresthesia (4421); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that the patient's implantable neurostimulator (ins).Caller could not confirm if mdt was the manufacturer.Caller said they have dbs implanted and, "a bunch of other stuff," and that sometimes the dbs relaxes them and sometimes it makes them shiver and "stuff like that." caller said that people can talk to them through the dbs, and those people have cameras, and those people can control whatever they want the caller's body to do.Caller noted that these issues are debilitating and have destroyed their life.Caller said they had been dealing with this issue for about 5 years and are getting really sick of it.Caller said they did some research with the fda and fcc, and they are pretty sure their dbs was an mdt product.Caller said there is no record of what they have implanted and no record of the caller was found.Caller said they reported the issue to their healthcare provider (hcp) but their hcp doesn't believe them and they think the caller was lying.Caller said they have exhausted their credit, and now they are getting death threats.Caller said they notified the cops.Caller mentioned that manufacturer people are linked to this issue but they did not wish to provide names for privacy reasons.Caller mentioned that they have literature coming for dbs and "urinary and fecal incontinence interstim." caller asked if there is device that is like a vest that has sensors that go every 2 feet that can "roll and give a therapeutic massage from where ever they are." caller said their reason for calling was to find if there is a legal department that deals with liability, because they were looking to get an attorney to help them with this issue.Agent reviewed that once the caller has an attorney, the attorney can contact the legal department.Agent did not ask for further event information because the caller wished to keep things confidential until they have an attorney.Additional information was received from the patient stating that somebody implanted a bunch of stuff inside the patient's body where the people could control it remotely and so the people had been doing all kinds of stuff to the patient such as making their body tingle and make them sweat.The caller stated they had been tracking it down as it has been going on for like 4 years, and so they had tracked the people down and got them to talk, and everything was pointing to all of the products coming from medtronic.The caller stated there was something in their balls where the people could make them pee, and that they had tried to make them poop their pants but hadn't done so yet.The caller stated the thing in their brain the people could do all kinds of stuff with, such as shock them.The caller stated the people could talk to the patient, and that they had cameras inside of the patient, so the people knew where the patient was and could hear and listen to everything they would say.The caller stated one of their legs was going numb as something passed through/went through their body so they had chest pains for a couple weeks and now their left leg, their foot specifically, goes dead where it just drops.The caller stated they talk to the people daily and have now been threatening the patient, saying crazy stuff like they'll be dead by tomorrow.The caller stated the threats were because there was supposedly a lawsuit or something that the people had won against medtronic with the stuff that was inside them and that the stuff had been purchased with a credit card and that instead of the things in their body doing whatever their purpose was, that they ended up being put inside of them and inquired about who to talk to, whether mdt or the fda and asked if there was any way for a mdt lawyer to talk to them and see if their name had been brought up in a court hearing in florida or california, and that the things inside them might have been gotten from overseas, and that they just found out medtronic had the cameras.Caller asked about 'elvision' and mdt pill cameras.The caller stated the people had some kind of vest that did therapeutic stuff that had sensors that were put 18 inches apart all throughout the patient's body from head to toe and patient was trying to figure out, as that was how the people were able to shock the patient, and that they had the sensors in their jaw so the people could shock their teeth and make the patient feel like they broke a tooth right down to the nerve.The caller inquired about who they could talk to about getting imaging done to find out what's all in them and asked for a mdt doctor.Pss reviewed and provided hcp name and number over the phone as caller did not have an email as the patient stated their phone had been hacked too, as they had recorded some of the stuff happening to them and had caught people following them, so they had taken videos, so the phone was hacked and all of the evidence was erased.Caller also stated they had exhausted there options and had spent a lot of money trying to get to the bottom of what they have inside them as the doctors they had that were not familiar with the product just looked at the patient like they didn't know what they were talking about.Caller stated they would be reaching out to hcp provided during call.Overall, pss documented reported information, provided hcp listing and redirected patient to see a healthcare provider to further address issue, and informed patient pss would reach out to contact to notify of situation and request.Pss notified (b)(6) over email of situation.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16592733
• MDR Text Key: 312236294
• Report Number: 2182207-2023-00514
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2023
• 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