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 Intracranial Hemorrhage (1891); Paresis (1998); Convulsion/Seizure (4406)

Event Date 08/22/2023

Event Type  Injury  

Event Description

Runge, j., nagel, j., schrader, c., blahak, c., weigel, r., wolf, m., heissler, h., dipl-ling,., saryyeva, a., krauss, j.Microelectrode recording and hemorrhage in functional neurosurgery: a comparative analysis in a consecutive series of 645 procedures.Journal of neurosurgery.2023.Doi: 10.3171/2023.8.Jns23613 summary: objective functional stereotactic neurosurgery including deep brain stimulation (dbs) and radiofrequency lesioning is well established and widely used for treatment of movement disorders and various other neurological and psychiatric diseases.Although functional stereotactic neurosurgery procedures are considered relatively safe, intracranial hemorrhage resulting in permanent neurological deficits may occur in 1%¿3% of patients.Microelectrode recording (mer) has been recognized as a valuable tool for refining the final target in functional stereotactic neurosurgery.Moreover, mer provides insight into the underlying neurophysiological pathomechanisms of movement disorders and other diseases.Nevertheless, there is an ongoing controversy on whether mer increases the risk for hemorrhage.The authors aimed to compare the risk of hemorrhage in functional stereotactic neurosurgical procedures with regard to the use of mer.Methods the authors performed a comparative analysis on a consecutive series of 645 functional neurosurgery proc edures, including 624 dbs surgeries and 21 radiofrequency lesionings, to evaluate whether the use of mer would increase the risk for hemorrhage.Mer was performed in 396 procedures, while no mer was used in 249 cases.The mer technique involved the use of a guiding cannula and a single trajectory when feasible.Postoperative ct scans were obtained within 24 hours after surgery in all patients and screened for the presence of hemorrhage.Results twenty-one intracranial hemorrhages were detected on the postoperative ct scans (3.2%).Of the 21 intra cranial hemorrhages, 14 were asymptomatic and 7 were symptomatic.Symptoms were transient except in 1 case.There was no statistically significant correlation between hemorrhage and the use of mer at any site (subdural, ventricle, trajectory, target, whether asymptomatic or symptomatic).There were 4 cases of symptomatic hemorrhage in the mer group (1%) and 3 cases in those without mer (1.2%).Conclusions intraoperative mer did not increase the overall risk of hemorrhage in the authors¿ experience using primarily a single mer trajectory and a guiding cannula.Reported events: 1.21 intracranial hemorrhages were detected on postoperative ct scans.14 of them were asymptomatic and 7 were symptomatic.There were no hemorrhages in the patients who received radiofrequency lesions.2.In the patients with symptomatic hemorrhage, symptoms were transient, except in 1 case of persistent mild hemiparesis due to hemorrhage along the intracerebral course of the dbs electrode.The patient who had a persistent neurological deficit was a 72-year-old man with pd who underwent stn dbs with mer and suffered a hemorrhage along the dbs trajectory.This patient had a seizure directly after dbs electrode implantation and it could not be determined whether hemorrhage was due to mer or to dbs electrode implantation per se."see attached literature article".

Manufacturer Narrative

Concomitant medical product: product id neu_ins_stimulator lot# serial# unknown product type implantable neurostimulator section d information references the main component of the system.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown, runge, j., nagel, j., schrader, c., blahak, c., weigel, r., wolf, m., heissler, h., dipl-ling,., saryyeva, a., krauss, j.Microelectrode recording and hemorrhage in functional neurosurgery: a comparative analysis in a consecutive series of 645 procedures.Journal of neurosurgery.2023.Doi: 10.3171/2023.8.Jns23613 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: 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: 18411200
• MDR Text Key: 331578548
• Report Number: 2182207-2023-02898
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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): Other
• Patient Age: 54 YR
• Patient Sex: Male