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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Migration or Expulsion of Device (1395); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Unspecified Infection (1930); Necrosis (1971); Cognitive Changes (2551); Dementia (4405); Convulsion/Seizure (4406); Hallucination (4428); Suicidal Ideation (4429); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  Injury  

Event Description

Purner d, hormozi m, weiss d, et al.Nationwide retrospective analysis of combinations of advanced therapies in patients with parkinson disease.Neurology.2023;101(21):e2078-e2093.Doi:10.1212/wnl.0000000000207858.Abstract background and objectives: advanced therapies (ats; deep brain stimulation [dbs] or pump therapies: continuous subcutaneous apomorphine infusion [csai], levodopa/carbidopa intestinal gel [lcig]) are used in later stages of parkinson disease (pd).However, decreasing efficacy over time and/or side effects may require an at change or combination in individual patients.Current knowledge about changing or combining ats is limited to mostly retrospective and small-scale studies.The nationwide case collection combinations of advanced therapies in pd assessed simultaneous or sequential at combinations in germany since 2005 to analyze their clinical outcome, their side effects, and the reasons for at modifications.Methods: data were acquired retrospectively by modular questionnaires in 22 pd centers throughout germany based on clinical records and comprised general information about the centers/patients, clinical (mini-mental status test/montréal cognitive assessment, movement disorder society¿sponsored revision of the unified parkinson's disease rating scale [mds-updrs], side effects, reasons for at modification), and therapeutical (ats with specifications, oral medication) data.Data assessment started with initiation of the second at.Results: a total of 148 at modifications in 116 patients were associated with significantly improved objective (median decrease of mds-updrs part iii 4.0 points [p <(><<)> 0.001], of mds-updrs part iv 6.0 points [p <(> <<)> 0.001], of mds-updrs part iv¿off-time item 1.0 points [p <(><<)> 0.001]) and subjective clinical outcome and decreasing side effect rates.Main reasons for anat modification were insufficient symptom control and side effects of the previous therapy.Subgroup analyses suggest addition of dbs in at patients with leading dyskinesia, addition of lcig for leading other cardinal motor symptoms, and addition of lcig or csai for dominant off-time.The most long-lasting therapy¿until requiring a modification¿was dbs.Discussion: changing or combining ats may be beneficial when 1 at is insufficient in efficacy or side effects.The outcome of an at combination is comparable with the clinical benefit by introducing the first at.The added at should be chosen dependent on dominant clinical symptoms and adverse effects.Furthermore, prospective trials are needed to confirm the results of this exploratory case collection.Classification of evidence this study provides class iv evidence that, in patients with pd, changing or combining ats is associated with an improvement in the mds-updrs or subjective symptom reporting.Reported events: the most common advanced therapy (at) changes were the replacement of a csai by a dbs.24 patients had levodopa-carbidopa intestinal gel (lcig) added to an existing dbs therapy and 19 patients had continuous subcutaneous apomorphine infusion (csai) added to an existing dbs.Of 111 dbs therapies: 2 were unilateral dbs of the subthalamic nucleus (stn), 104 were bilateral stn, 4 were bilateral globus pallidus (gpi) and 1 was bilateral dbs of the pedunculopontine nucleus.For many side effect categories, the percentage of affected patients decreased after the respective modification and did not reach the baseline level at the last assessment.Both dbs and csai reduced device-associated adverse effects (-5.7% and -11.8%)and neurologic complications (-20.8% and -14.7%) effectively; dbs addition reduced furthermore cutaneous side effects (-15.1%) after dbs was added: 24 patients had neurological side effects 14 patients had neuro-psychiatric side effects 1 patient had gastro-intestinal side effect 2 patients had device associated side effect 1 patient had cardiovascular side effect 7 patients had periprocedural side effect.Neurological side effects: 6 patients had dysphagia pre and post modifications.Dysphagia was the reason for modification of the ats for 2 patients.2 patients had indication for percutaneous endoscopic jejunostomy (pej) due to dysphagia.2 patients had pej dislocation pre-modifications and 4 patients had pej dislocation post modifications.Pej dislocation was the reason for modification of the ats for 4 patients.2 patients had pej infection pre-modifications and 5 patients had pej infection post modifications.Pej infection was the reason for modification of the ats for 1 patient.1 patient had epilepsy pre-modifications.Neuropsychiatric: 2 patients had delirium pre-modification and 1 patient had delirium post modifications.Delirium was the reason for modification of the ats for 1 patient.2 patients had dementia pre-modification and 3 patients had dementia post modifications.Dementia was the reason for modification of the ats for 1 patient.3 patients had dopamine dysregulation syndrome pre-modifications and 2 patients had dopamine dysregulation syndrome post modifications.Dopamine dysregulation syndrome was the reason for modification of the ats for 4 patients.28 patients had hallucination pre-modifications and 11 patients had hallucination post modifications.Hallucinations were the reason for modification of the ats for 22 patients.5 patients had suicide pre-modifications and 1 patient had suicide post modification.Suicide was the reason for modification of the ats for 1 patient.5 patients had suicidal thoughts pre-modification.1 patient had suicide attempt pre-modifications and post modifications.Suicide attempt was the reason for modification of the ats for the patient.4 patients had delusion pre-modifications and 1 patient had delusions post modifications.Delusion was the reason for modification of the ats for the 4 patients.Device-associated: 3 patients had electrode infection pre-modifications.Electrode infection was the reason for modification of the ats for 1 patient.5 patients had infection of dbs impulse generator pre-modifications.Infection of the dbs impulse generator was the reason for modification of the ats for 7 patients.Cutaneous: 4 patients had abdominal wall induration pre-modifications and 1 patient had abdominal wall induration post modifications.Abdominal wall induration was the reason for modification of the ats for the patients.2 patients had skin necrosis pre-modifications and 1 patient had skin necrosis post-modifications.Skin necrosis was the reason for modification of the ats for the patients.Periprocedural: 3 patients had malpuncture post modifications.

Manufacturer Narrative

D10.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unkonwn, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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.B.5.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence will be sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Https://www.Neurology.Org/doi/10.1212/wnl.0000000000207858 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.

• 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: 18407064
• MDR Text Key: 331471367
• Report Number: 2182207-2023-02891
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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): Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male