MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	37603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	06/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id 37603 (serial: (b)(6)); product type: 0197-implantable neurostimulator; implant date ; explant date g2: citation: authors: lee a.T., han k.J., nichols n., sudhaker v.R., burke j.F., wozny t.A., chung j.E., volz m.M., ostrem j.L., martin a.J., larson p.S., starr p.A., wang d.D.Targeting accuracy and clinical outcomes of awake versus asleep interventional magnetic resonance imaging-guided deep brain stimulation for parkinson¿s disease: the university of california, san franc.Neurosurgery 2022.Doi: 10.1227/neu.0000000000002111 · 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.This event was originally reported in 2182207-2023-02767.After receiving specific device and patient information for these reported events, each patient will receive their own regulatory report.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Lee a.T., han k.J., nichols n., sudhaker v.R., burke j.F., wozny t.A., chung j.E., volz m.M., ostrem j.L., martin a.J., larson p.S., starr p.A., wang d.D.Targeting accuracy and clinical outcomes of awake versus asleep interventional magnetic resonance imaging-guided deep brain stimulation for parkinson¿s disease: the university of california, san franc neurosurgery 2022 doi: 10.12 27/neu.0000000000002111 abstract: background: interventional mri (imri)-guided implantation of deep brain stimulator (dbs) leads has been developed to treat patients with parkinson¿s disease (pd) without the need for awake testing.Objective: direct comparisons of targeting accuracy and clinical outcomes for awake stereotactic with asleep imri-dbs for pd are limited.Methods: we performed a retrospective review of patients with pd who underwent awake or imri-guided dbs surgery targeting the subthalamic nucleus or globus pallidus interna between 2013 and 2019 at our institution.Outcome measures included unified parkinson¿s disease rating scale part iii scores, levodopa equivalent daily dose, radial error between intended and actual lead locations, stimulation parameters, and complications.Results: of the 218 patients included in the study, the imri cohort had smaller radial errors (imri: 1.27 ± 0.72 mm, awake: 1.59 ± 0.96 mm, p <(><<)>.01) and fewer lead passes (imri: 1.0 ± 0.16, awake: 1.2 ± 0.41, p <(><<)>.01).Changes in unified parkinson¿s disease rating scale were similar between modalities, but awake cases had a greater reduction in levodopa equivalent daily dose than imri cases (p <(><<)>.01), which was attributed to the greater number of awake subthalamic nucleus cases on multivariate analysis.Effective clinical contacts used for stimulation, side effect thresholds, and complication rates were similar between modalities.Conclusion: although imri-dbs may result in more accurate lead placement for in tended target compared with awake-dbs, clinical outcomes were similar between surgical approaches.Ultimately, patient preference and surgeon experience with a given dbs technique should be the main factors when determining the ¿best¿ method for dbs implantation.Reported event: 1) 1 patient in the imri group had an intraparenchymal hemorrhage.Additional information was received from the healthcare provider (hcp) stating that the adverse events listed in the article did not relate directly to medtronic devices/products.No medtronic devices/products are available for evaluation.The patient's listed in adverse event 5 did not have hemicraniectomies.See attached literature article.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19049368
• Report Number: 3004209178-2024-08543
• Device Sequence Number: 7355280
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/05/2024
• Date Device Manufactured: 04/01/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 83 KG