| Model Number 37612 |
| Device Problems
Energy Output Problem (1431); Charging Problem (2892); Unauthorized Access to Computer System (3025); Insufficient Information (3190)
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| Patient Problems
Fatigue (1849); Headache (1880); Device Overstimulation of Tissue (1991); Pain (1994); Tinnitus (2103); Dysphasia (2195); Anxiety (2328); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Cognitive Changes (2551)
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| Event Date 01/01/2017 |
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Event Type
Injury
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Manufacturer Narrative
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(pma): this model of neurostimulator (model #: 37612) is not indicated for use in dystonia patients.This device was used for an off-label indication.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for acute cervical dystonia.It was reported the patient¿s deep brain stimulation (dbs) was being hacked.The patient stated they needed help researching the issue and claimed to have ¿circumstantial evidence in neighborhood and from the internet.¿ it was noted the patient¿s family could tell there was ¿serious something wrong with the patient¿s brain.¿ it was stated the patient had, ¿proof, medical equipment, medical records,¿ as well.No further complications were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the healthcare professional stating they were unaware of the occurrence.The patient's mother had indicated the patient had psychiatric issues.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the consumer indicating their device had been hacked.They were getting on edge as they were unable to sleep from hearing voices.They were given pills, however they were certain they were really hacked.This had been occurring before dbs, however had gotten much worse since getting implanted.The patient heard people who lived there and were talking to them; if a megaphone was on a low setting, they would still be able to hear them.When they used certain appliances, put their hand in water, took a shower, turns their fan on, did laundry, or used a hair dryer they could hear what the voices were trying to say.The patient was sent physician listings and directed to follow-up with their healthcare provider regarding the potential hacking.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received: it was reported that the patient stated they had been on some credible websites that talked about dbs implants could be hacked.The patient reported that they thought someone had hacked their dbs implant because they were hearing voices and had been committed twice for hearing voices and nobody believed them.The patient asked if the dbs implant could be hacked.The patient reported when they turned off the implant they voices went away.The patient reported those voices were real and they were on 10 different scripts.The patient stated they talked with police officers and everyone thought they were crazy.The patient stated somebody had committed a "heinous crime" and should be put in jail.The patient asked what the different symbols meant on the recharger manual.There were no further complications reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported the issue was still not resolved and was trying to prove the electrodes were picking things up from the wifi.Additional information was received (b)(6) 2018 stating the patient had an appointment scheduled for (b)(6) 2018.
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Manufacturer Narrative
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Due to imdrf harmonization, any previously submitted conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received reported the patient had a serious issue.They had compelling evidence they had found on line that the dbs can be hacked through the internet or wi-fi, bluetooth.It was stated their ins had been hacked, and they had been seeing the police.The patient had been hearing voices and was sent to a psychiatrist who then over medicated the patient.Then the patient would go to a behavior health association center.This has happened to them 2 times.It was noted the patient had voices they heard that are non-stop.This is for 24 hours a day, and the patient never got a break from it.The patient stated the voices were real and no joke.The device had got them put in jail because the voices told them to knock on someone's door, and they got arrested.The voices promised them they would be rescued by a specific person and be awarded money.This had been going on for so long that they were exhausted, it was affecting their work, study habits, sleep, and it was affecting everything.They couldn't relax anymore.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the rep stating the patient went to the an appointment with the hcp on (b)(6) 2018.He was no longer hearing voices and the dbs was working very well according to the patient.According to the hcp, the patient needs psychiatry consults and direction but the patient did not agree to this.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received: it was reported that back in (b)(6) 2017 , the patient¿s family threw a huge party with food and fireworks.The patient reported they were hearing things through their electrodes.One night they stayed at their grandmothers house and was having issues with their dbs and somebody from the police station came over and talked with them.Later that night they heard (b)(6) through their electrodes.The patient said they were in a psych ward about 8 or 9 times after they were hearing voices in their head after getting their dbs in 2015 or 2016.They also messed with the remote sometimes to change the frequency and every time they would do that, they heard voices about being awarded money.The patient stated they have torticollis and it¿s painful.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient inquired why their previous email was not replied to.They stated they were "hearing things through" their deep brain stimulation (dbs) system.They stated it was happening at the time of reporting and it caused a "huge corundum" because they're preparing for their property and casualty state exam.The patient inquired whether it was possible to "hear things through" a dbs device.They also inquired asking why "no one" would explain something they find "rather odd," that when a named physician asked the patient to "slice (their) wrist" why they knew where the patient lived.They stated they "keep getting messages" they can see through their left eye and it was a "very opaque" visual.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received indicating the patient was having difficulty with their deep brain stimulation.They were having pain and visual/auditory hallucinations.The patient was unable to work due to their condition.No further complications were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from a consumer indicated they hypothesize the (b)(6) had been hacking their deep brain stimulation (dbs) since they live in a closer radius to their home.They had been locked up in a psych ward in (b)(6) for fifteen days.They started hearing odd things throughout their device it was coming from the (b)(6) of their parent's home which is toward (b)(6).
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the patient's mother stating she texted someone from the uk who wrote a paper about device hacking and the person texted her back saying hacking is a possibility.The caller reported the police department got a court order and had him put in a behavioral adult unit.The caller reported the patient was not a criminal or a bad person but was going through a rough patch.The caller stated she had the managing hcp do a cat scan "because maybe those electrodes up there were pushing up against something" or maybe the device was causing something.The caller did not believe it was psychosis.The caller stated the patient believed the "wi-fi was picking up signals" and also believed the first doctor he worked with may have used him as a guinea pig.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from a consumer indicated they apologized for their eradicate behavior, but they had been experiencing some frightening things with their deep brain stimulation (dbs).Ever since they signed up online for the air force, marine corps, and army, things had gotten really crazy.They stated they needed to speak with their healthcare provider (hcp).No further complications were reported or anticipated with this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received that the patient was hearing "electrodes ringing in the right and/or left electrode from time to time and it was reiterated that they were able to hear voices through their electrodes.The patient noted they were concerned about this.The patient contacted a medical university patient relations, the manufacture representative, and the police on (b)(6) 2019 as a follow-up, stating the majority of the voices the patient was recognizing come from the town of the police contacted and they wanted to know why no one was answering their requests about being harassed through their deep brain stimulation (dbs) electrodes.
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Event Description
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Additional information was received from the consumer reporting they were at the beach today, fell asleep, and while they were sleeping, someone took their patient programmer (pp) and adjusted their stimulation to very high, and stole the pp.They stated whoever stole the pp knew to have the pp over the ins to adjust the stimulation.The stimulation is so high, they are having difficulty speaking.They did not realize what happened until they woke up while at the beach.The patient stated they will call back.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the patient the doctor and his staff hacked the patient's deep brain stimulation device.Patient stated that they had been tortured like that man on zero dark thirty, but that patient was innocent.Patient heard the doctor's voice through their dbs telling the patient to slice their wrist, more than one time.Patient has been terrorized because the doctor has been hacking their device.On many of the encounters patient had been asked to kill himself.And patient noted that this considered telepathic messages.Patient stated that they had complained to the police department and had at least four years of records of the patient complaining about my deep brain stimulation being hacked.Patient could not point a finger on who was doing this.Patient mentioned that the funny thing is that they had been to a psych ward three times because everyone thinks this is not possible.Patient states they know this is real, and was begging to be saved from this nonstop telepathic messages.The doctor stated that the doctor developed dystonia in 2010.The patient's treatments have included deep brain stimulation and medications.Currently the patient had difficulty with the dbs, patient was having pain and visual/auditory hallucinations and the patient was unable to work due to their condition.Patient also noted that certain entities have been telling him that whoever hacked into his dbs can allegedly see through the patient's eyes.To be more specific, the patient has heard certain people and/or entities tell me that they can only see through my left eye.No further patient complications were reported/ anticipated as a result of this event.
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Manufacturer Narrative
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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.
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Event Description
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Additional information was received that patient's complaint continues.Patient has been feeling "compromised" since 2016 because the programmer was hacked.Patient clarified this as it is technology reading his mind and life is on hold, having to stop graduate school.Patient states he sent back the programmer about a month ago and would like it analyzed.Patient was scheduled with the neurologist to discuss this issue.A manufacturer representative additionally reported that the patient feels his implantable battery has been compromised and would like to make sure it has not been hacked.Reports were retrieved and submitted for review.
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Manufacturer Narrative
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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.
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Event Description
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Patient has an appointment with provider on (b)(6).Additional information was received from the manufacturer representative regarding the patient's claim that he is being "hacked" adding that it is especially when patient recharges his implant.Patient has been vague as to how or why he believed he's been hacked.A manufacturer representative reported that patient has a history of mental illness.
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Manufacturer Narrative
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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.
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Event Description
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Patient emailed patient services stating their dbs is an unethical hack and it's frequent 24/7.They have not been able to resolve this.Patient requested help to swap out equipment for something safer, surgical steel electrodes.Patient states someone has been compromising them.They state they are "in the emf and internet as we know it." they state they "feel and hear in the open air." they report previous neurologist was unsuccessful helping them have equipment removed and replaced with something safer.
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Event Description
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Information was received from the patient.The patient mentioned that their ins has been turned off because it caused them a lot of physical and mental pain.They were looking to have implant and lead remove in the next 5 months and inquired about how to send devices to manufacturer for analysis.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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.
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Event Description
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Additional information received from the consumer reported the device had been off for 8 months and there was a ¿security breach in 2015.¿ the consumer was trying to get the device removed but was working with a new physician.The consumer also mentioned ¿3rd party incident response playbook.¿ due to the ¿breach¿ they were having pain, headaches, sleep disturbances, and sleep deprivation.
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Search Alerts/Recalls
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