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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); High impedance (1291); Migration or Expulsion of Device (1395); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Pulmonary Embolism (1498); Abscess (1690); Bradycardia (1751); Hematoma (1884); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Paresis (1998); Skin Erosion (2075); Dysphasia (2195); Irritability (2421); Hydrocephalus (3272); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2023

Event Type  Injury  

Manufacturer Narrative

A.2.This value is the average age 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.D10.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, refer to manufacturer report #2182207-2023-02215 for related device.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

Servello, d., galbiati, t.F., iess, g.Et al.Complications of deep brain stimulation in parkinson¿s disease: a single-center experience of 517 consecutive cases.Acta neurochir (2023).Https://doi.Org/10.1007/s00701-023-05799-w abstract background the number of deep brain stimulation (dbs) procedures is rapidly rising as well as the novel indications.Reporting adverse events related to surgery and to the hardware used is essential to define the risk-to-benefit ratio and develop novel strategies to improve it.Objective to analyze dbs complications (both procedure-related and hardware-related) and further assess potential predictive factors.Methods five hundred seventeen cases of dbs for parkinson¿s disease were performed between 2006 and 2021 in a single center (mean follow-up: 4.68 ± 2.86 years).Spearman¿s rho coefficient was calculated to search for a correlation between the occurrence of intracerebral hemorrhage (ich) and the number of recording tracks.Multiple logistic regression analyzed the probability of developing seizures and ich given potential risk factors.Kaplan-meier curves were performed to analyze the cumulative proportions of hardware-related complications.Results mortality rate was 0.2%, while permanent morbidity 0.6%.2.5% of cases suffered from ich which were not influenced by the number of tracks used for recordings.3.3% reported seizures that were significantly affected by perielectrode brain edema and age.The rate of perielectrode brain edema was significantly higher for medtronic¿s leads compared to boston scientific's(¿2 (1)= 5.927, p= 0.015).12.2% of implants reported hardware-related complications, the most common of which were wound revisions (7.2%).Internal pulse generator models with smaller profiles displayed more favorable hardware related complication survival curves compared to larger designs (x2 (1)= 8.139, p= 0.004).Conclusion overall dbs has to be considered a safe procedure, but future research is needed to decrease the rate of hardware related complications which may be related to both the surgical technique and to the specific hardware¿s design.The increased incidence of perielectrode brain edema associated with certain lead models may likewise deserve future investigation.Reported events: 2.13 patients had intracerebral hemorrhages.12 of the cases occurred in the perioperative period.Eight patients developed neurological deficits due to intraparenchymal bleeding.Those patients were treated according to the size of hematoma and/or presence of intraventricular bleeding.Two patients required hematoma evacuation - one of the patients developed a major venous hemorrhagic infarct following coagulation of a superficial convexity, which required an urgent surgical intervention of hematoma evacuation and required evd placement for intraventricular hemorrhage.Of those discussed, 4 patients had a complete recovery from the neurological deficit with mild or no disability.However, 3 patients had permanent hemiparesis and aphasia due to the hemorrhage.One patient required surgical revision for electrode explantation.3.17 patients had seizures.5 of the patients had intraoperative seizures.Occurrence of perielectrode edema and age were found to be significant predictors of this complication.None of the 17 patients suffered from preoperative seizure disorders or from other neurological disease besides parkinson's disease.4.16 patients had misplaced electrodes.4 lead misplacements required intraoperative repositioning.7 patients required surgical revision for electrode explantation.5.10 patients had lead infections that required surgical revision for electrode explantation.None of these patients showed significant comorbidities.Only one case of frank cerebral (intracranial) abscess, which was subsequently treated with surgical removal of the electrode and stereotactic drainage of the abscess.The remaining cases of infections involved the surgical wounds (either cranial or concerning the implantable neurostimulator (ins)).Five cases started from the ins and rapidly extended along the extension wires, resulting in both the ins and extension wires being removed to achieve infection healing and to prevent intracranial dissemination of the infection.All patients started antibiotic therapy for 3 weeks.Two patients were reoperated with a successful reprise of stn-dbs.6.One patient had hydrocephalus.7.One patient had bradycardia and hypotension intraoperative that led to interruption of surgery.8.One patient had pulmonary embolism about 3 weeks after surgery.9.37 patients had wound dehiscence so wound revision was performed due to skin erosion.11 of these patients necessitated a second operation, 3 a third operation, and 4 a fourth operation.Only 1 patient underwent more than 3 wound revisions, which the system was not removed.16 patients required surgical revision for electrode explantation.10.Four patients had severe agitation intraoperative, which in three cases, surgery resulted in the inability to complete the procedure.  11.Two patients had no clinical response that required surgical revision for electrode explantation.12.Four patients had lead migration that required surgical revision for electrode explantation.13.Two patients had hardware-related dysfunctions that required surgical revision for electrode explantation.14.19 patients had lead extension revision due to high impedances.15.12 patients had lead extension revision due to breakage/disconnection of one or more extensions.16.Three patients had lead migration/fracture/malfunction that resulted in surgical revision.  17.Four patients had implantable neurostimulator (ins) migration that resulted in surgical revision.The following device specifics were provided: ins models - kinetra (7428), activa pc (37601), and activa rc (37612).

Manufacturer Narrative

H6.The coding was reviewed and updated upon further review of information.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: 18022348
• MDR Text Key: 326744521
• Report Number: 2182207-2023-02219
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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: 01/22/2024
• 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): Disability; Required Intervention
• Patient Age: 61 YR