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

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Seroma (2069); Burning Sensation (2146); Depression (2361); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the patient alleged they had a dbs implanted them by a nurse without them knowing it was being implanted.The caller stated that they do not have parkinson's.The caller could not confirm the manufacturer of the dbs, but alleged that it was the manufacturer.The caller stated that they initially went in to have a breast implant removed in 2019 because of an infection.The caller stated that the surgeon wanted to put the breast implant back in, but the patient told them not to because of the infection.The caller indicated that this was when the dbs was implanted without them knowing.The caller stated that the dbs was being used "more like a torture device." the caller stated that they are in severe pain from their spine to their pelvis area, and have a burning sensation in their body.The caller stated that they are allergic to "whatever was placed" in them, and that they have gone back and forth with infections.The caller mentioned that they have gone to the emergency room, but nobody has been able to help them.The caller stated that their records were messed up with someone at the hospital.The caller asked for a referral to someone who could help them.Agent reviewed role of patient services, and the caller disconnected the call shortly thereafter.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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

Additional information was received from a consumer reporting that dbs surgery was done on (b)(6) 2019.The patient mentioned that they do not have parkinson's disease nor essential tremor.They can feel something in the left side of their chest and when they went to the breast center for imaging, they were told it was there.They were told they have dbs and spine, then told nothing.The patient had to file for identity theft.They said the dbs procedure was done in a clinical trial through an "anesthetist thing" and they did not consent to it.They remember they drilled holes in their brain but they were drugged/sedated and people were shoving papers saying "sign this sign this", it was abuse (abuse by medical products after threats to harm them).A lady threatened them brain harm in 2019 and prior, another person.When asked about dbs and scar, the patient said there was a cut on their neck to their the whole breast was cut open from neck/thyroid to shoulder was cut open but they did not have any external equipment.Their real family or husband were not notified prior to the surgery.They want it removed.They tried to work with the patient advocate and had to take the doctor to court.The patient said they could not do what they needed to do because they fell and they have allergies to heavy metal.The patient said it caused them injuries and depression.They wound up with a blood tumor in their neck, hemorrhaging in the hospital for their kidneys to be drained and stuff it was just getting worse and worse.They life is destroyed by causing them the wrong surgeries.The issue was not resolved.The patient mentioned that infection, falling, serious injury and spine issues to feeling something on right side through belly button issues were unrelated medical history.

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.

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

Additional information was received from a consumer reporting that they were threatened with brain harm/shock since 2006 to destroy their life and disable them.Prior, they were normal and brain was normal.They were never given any controller and mentioned one is using the product illegally, controller set on conversion, to torture them knowing they are allergic to metal copper, change their sex, alter their face, ruined their teeth, nose, mouth, and outward.

• 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: 14197063
• MDR Text Key: 292610644
• Report Number: 2182207-2022-00688
• Device Sequence Number: 1
• Product Code: MHY
• 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,Followup,Followup,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/22/2023
• 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
• Patient Outcome(s): Required Intervention