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

Model Number 37612

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

Patient Problems Intracranial Hemorrhage (1891); Unspecified Infection (1930); Convulsion/Seizure (4406)

Event Date 10/05/2023

Event Type  Injury  

Event Description

Giordano, m., innocenti, n., rizzi, m., rinaldo, s., nazzi, v., eleopra, r., levi, v.Incidence and management of idiopathic peri-lead edema (iple) following deep brain stimulation (dbs) surgery: case series and review of the literature.Clinical neurology and neurosurgery 234 (2023).Doi: 10.1016/j.Clineuro.2023.108009 summary: objective: idiopathic peri-lead edema (iple) is being increasingly described as a potential complication occurring after dbs surgery.Its incidence and relationship to post-operative symptoms, though, are still poorly defined and its understanding and management yet limited.Methods: we reviewed delayed (= 72 h) post-operative ct imaging of patients who underwent dbs surgery at our institution.A comparison of clinical and laboratory findings was carried out between patients with iple and controls.Results: 61 patients, accounting for 115 electrodes, were included.Incidence of iple was 37.7 % per patient and 29.5 % per electrode.Patients with iple were significantly older than controls (52.82 ± 15.65 years vs 44.73 ±18.82 years, p = 0.04).There was no difference in incidence of new-onset neurological symptoms between patients with iple and controls.Longer operative time (180.65 ± 34.30 min vs 158.34 ± 49.28 min, p = 0.06) and a greater number of mers per electrode were associated with iple (3.37 ± 1.21 vs 3.00 ± 1.63, p = 0.089), though these comparisons did not meet the statistical significance.None of the patients with iple underwent hardware removal, with iple vanishing spontaneously over months.Conclusions: iple is an underestimated, benign event that may occur after dbs surgery.Age, longer operative time and mer use may represent risk factors for iple formation, but further studies are needed.The presence of post-operative neurological symptoms and fever was not associated with iple presence, highlighting its benign nature and suggesting that empiric treatment may not be always justified.Reported events: 1.8 patients who were implanted with dbs electrodes were excluded because of the signs of asymptomatic peri-electrode haemorrhages observed on post-operative imaging.2.2 patients who were implanted with dbs electrodes were not included because of post-operative signs of infection requiring lead removal.3.1 patient who was implanted with dbs electrodes showed symptoms of seizures."see attached literature article".

Manufacturer Narrative

Concomitant medical product: product id 3387 lot# unknown, product type lead product id 37612 serial# unknown product type implantable neurostimulator product id 3387 lot# unknown product type lead product id 37612 lot# serial# unknown product type implantable neurostimulator product id 3387 lot# unknown serial# section d information references the main component of the system.Other relevant device(s) are: product id: 3387, serial/lot #: unknown, product id: 37612, serial/lot #: unknown, ; giordano, m., innocenti, n., rizzi, m., rinaldo, s., nazzi, v., eleopra, r., levi, v.Incidence and management of idiopathic peri-lead edema (iple) following deep brain stimulation (dbs) surgery: case series and review of the literature.Clinical neurology and neurosurgery 234 (2023).Doi: 10.1016/j.Clineuro.2023.108009 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 [or the date that the article was accepted for publication] 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 has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.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.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: ACTIVA
• 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: 18097037
• MDR Text Key: 327698204
• Report Number: 2182207-2023-02360
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• 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
• Patient Age: 48 YR
• Patient Sex: Male