MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number NEU_INS_STIMULATOR

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problems Emotional Changes (1831); Headache (1880); Muscular Rigidity (1968); Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Convulsion/Seizure (4406); Suicidal Ideation (4429)

Event Date 05/10/2023

Event Type  Injury  

Manufacturer Narrative

Country of origin: great britain it was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.B.3.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.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

Ahmed saeed yahya, meena naguib, shakil khawaja.Psychiatric disorder in dyt1 dystonia.Progress in neurology and psychiatry.Doi: 1 0.1002/pnp.789.Dyt1 dystonia is a rare and genetically inherited childhood onset dystonia.Psychiatric comorbidity is increased in patients with dystonia.Here the authors present the case of a 25-year-old male with dyti dystonia, previously treated with deepbrain stimulation, who came to the attention of secondary care after a near fatal suicide attempt.The authors also summarise their findings from a literature search on psychiatric disorder in primary dystonia secondary to the dyt1 gene.Reported events:  reported events: it was reported that the patient had a near-fatal suicide attempt.They were found in their bedroom with a cable tied around their neck.The family had trouble getting through the door and found them on the floor non-responsive.The patient couldn't recall the details of the event but a few days prior their partner had told them their relationship had ended.Before this as well the patient started getting seizures after their dbs implant and developed focal-onset epilepsy.An eeg tracing was contraindicated because of the implant.During 2016 there were concerns about the patient's persistent low mood.Their sleep was disrupted and there was evidence of anhedonia.They attributed their mood difficulties to personal stressors.With newer medications their mood improved, however it was discontinued after one month because they had their first seizure in 2 years after the medication was initiated.They didn't have recurrence of seizures once they stopped their medication but mentioned prodromal symptoms.Their mood gradually improved without any further pharmacological intervention although they still had two more seizures even after the medication was discontinued.They also had migraines which were worse since the recurrence of seizures, and noticed whenever their battery was low that they would get symptoms.So they tried to maintain their battery level to keep their symptoms controlled.The patient described slower mobility and moderate to severe generalized pain, including recurrent headaches, along with early morning stiffness and pain.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 17298877
• MDR Text Key: 318777620
• Report Number: 2182207-2023-01343
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• 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): Other