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 Problem Cognitive Changes (2551)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id neu_ins_stimulator (serial: unknown); product type: 0197-implantable neurostimulator; implant date ; explant date product id neu_ins_stimulator (serial: unknown); product type: 0197-implantable neurostimulator; implant date ; explant date product id neu_ins_stimulator (serial: unknown); product type: 0197-implantable neurostimulator; implant date ; explant date product id neu_ins_stimulator (serial: unknown); product type: 0197-implantable neurostimulator; implant date ; explant date product id neu_ins_stimulator (serial: unknown); product type: 0197-implantable neurostimulator; implant date ; explant date product id neu_ins_stimulator (serial: unknown); product type: 0197-implantable neurostimulator; implant date ; explant date product id neu_ins_stimulator (serial: unknown); product type: 0197-implantable neurostimulator; implant date ; explant date g2: citation: authors: micol avenali, roberta zangaglia, giada cuconato, ilaria palmieri, alberto albanese, carlo alberto artusi, marco bozzali, giovanna calandra-buonaura, francesco cavallieri, roberto cilia, antoniangela.Are patients with gba¿parkinson disease good candidates for deep brain stimulation? a longitudinal multicentric study on a large italian cohort.Journal of neurology, neurosurgery and psychiatry 2023.Do: 10.1136/ jnnp-2023-332387 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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

Micol avenali, roberta zangaglia, giada cuconato, ilaria palmieri, alberto albanese, carlo alberto artusi, marco bozzali, giovanna c alandra-buonaura, francesco cavallieri, roberto cilia, antoniangela cocco, filippo cogiamanian, fabiana colucci, pietro cortelli, alessio di fonzo, roberto eleopra, giulia giannini, alberto imarisio, gabriele imbalzano, claudia ledda, leonardo lopiano, maria chiara malaguti, francesca mameli, raffaella minardi, pierfrancesco mitrotti, edoardo monfrini, francesca spagnolo, cristina tassorelli, francesca valentino, franco valzania, claudio pacchetti, enza maria valente.Are patients with gba¿parkinson disease good candidates for deep brain stimulation? a longitudinal multicentric study on a large italian cohort.Journal of neurology, neurosurgery and psychiatry.Doi: 10.1136/ jnnp-2023-332387.Abstract background gba variants increase the risk of developing parkinson disease (pd) and influence its outcome.Deep brain stimulation (dbs) is a recognised therapeutic option for advanced pd.Data on dbs longterm outcome in gba carriers are scarce.Objective to elucidate the impact of gba variants on long-term dbs outcome in a large italian cohort.Methods we retrospectively recruited a multicentric italian dbs-pd cohort and assessed: (1) gba prevalence; (2) pre-dbs clinical features; and (3) outcomes of motor, cognitive and other non-motor features up to 5 years post-dbs.Results we included 365 patients with pd, of whom 73 (20%) carried gba variants.5-year follow-up data were available for 173 pd, including 32 mutated subjects.Gba-pd had an earlier onset and were younger at dbs than non-gba-pd.They also had shorter disease duration, higher occurrence of dyskinesias and orthostatic hypotension symptoms.At post-dbs, both groups showed marked motor improvement, a significant reduction of fluctuations, dyskinesias and impulsive-compulsive disorders (icd) and low occurrence of most complications.Only cognitive scores worsened significantly faster in gba-pd after 3 years.Overt dementia was diagnosed in 11% non-gbapd and 25% gba-pd at 5-year follow-up.Conclusions evaluation of long-term impact of gba variants in a large italian dbs-pd cohort supported the role of dbs surgery as a valid therapeutic strategy in gba-pd, with long-term benefit on motor performance and icd.Despite the selective worsening of cognitive scores since 3 years post-dbs, the majority of gba-pd had not developed dementia at 5-year follow-up.Reported events: 1.It was reported that 27 patients had experienced hallucinations at 3 and 5 year follow up.2.It was reported that 146 patients had experienced depression at 3 and 5 year follow up 3.It was reported that 318 patients had experienced an inability to walk, recurrent falls and freezing of gait at 3 and 5 year follow up.4.It was reported that 45 patients had experienced urinary incontinence at 3 and 5 year follow up.5.It was reported that 40 patients had experienced impulsive-compulsive disorders at 3 and 5 year follow up.6.It was reported that 33 patients had experienced orthostatic hypotension at 3 and 5 year follow up.7.It was reported that 479 patients had experienced the on-off phenomenon and the wearing-off phenomenon at 3 and 5 year follow up.8.It was reported that 222 patients had experienced dyskinesia at 3 and 5 year follow up.

• 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: 18271274
• MDR Text Key: 329776187
• Report Number: 2182207-2023-02688
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/05/2023
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Other