MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SUMMIT RC+S INS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B35300R

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

Patient Problems Intracranial Hemorrhage (1891); Muscular Rigidity (1968); Scar Tissue (2060); Discomfort (2330); Dyskinesia (2363); Convulsion/Seizure (4406)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off the date of publication of the article as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.Other relevant device(s) are: product id: 3389, serial/lot #: unknown; product id: 3387, serial/lot #: unknown; product id: neu_unknown_ext, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Mitchell, k.T., schmidt, s.L., cooney, j.W., grill, w.M., peters, j., rahimpour, s., lee, h.J., jung, s.H., mantri, s., scott, b., lad, s.P.,& turner, d.A.(2022).Initial clinical outcome with bilateral, dual-target deep brain stimulation trial in parkinson disease using summit rc + s.Neurosurgery, publish ahead of print.Https://doi.Org/10.1227/neu.0000000000001957 background: deep brain stimulation (dbs) is an effective therapy in advanced parkinson disease (pd).Although both subthalamic nucleus (stn) and globus pallidus (gp) dbs show equivalent efficacy in pd, combined stimulation may demonstrate synergism.Objective: to evaluate the clinical benefit of stimulating a combination of stn and gp dbs leads and to demonstrate biomarker discovery for adaptive dbs therapy in an observational study.Methods: we performed a pilot trial (n = 3) of implanting bilateral stn and gp dbs leads, connected to a bidirectional implantable pulse generator (medtronic summit rc + s; nct03815656, ide no.G180280).Initial 1-year outcome in 3 patients included unified pd rating scale on and off medications, medication dosage, hauser diary, and recorded beta frequency spectral power.Results: combined dbs improved pd symptom control, allowing >80% levodopa medication reduction.Therewas a greater decrease in off-m edication motor unified pd rating scale with multiple electrodes activated (mean difference from off stimulation off medications 18.2, range 25.5 to 12.5) than either stn ( 12.8, range 20.5 to 0) or gp alone ( 9, range 11.5 to 4.5).Combined dbs resulted in a greater reduction of beta oscillations in stn in 5/6 hemispheres than either site alone.Adverse events occurred in 2 patients, including a small cortical hemorrhage and seizure at 24 hours postoperatively, which resolved spontaneously, and extension wire scarring requiring revision at 2 months postoperatively.Conclusion: patients with pd preferred combined dbs stimulation in this preliminary cohort.Future studies will address efficacy of adaptive dbs as we further define biomarkers and control policy.Reported events: 1.One patient had one small, delayed (24 hours) postoperative cortical hemorrhage 1 cm diameter) at the lead entry point.The small hemorrhage was not present on intraoperative or postoperative ct scans within 12 hours but presented after an isolated generalized seizure at 24 hours postoperatively.The patient was placed on levetiracetam for 3 months without seizure recurrence.A postoperative scan at 2 weeks showed resolution of the hemorrhage.2.Another patient developed tightness of extensions in theneck at 6 weeks postoperatively (related to the bulky, dual 40-cm forked extensions needed to connect 4 leads to a single summit rc + s ins).They were fully treated by extension revision surgery to longer (60 cm) extensions with no long-term sequelae and no effect on stimulation benefit.This patient also developed postoperative, unilateral leg dyskinesia off all parkinson's disease medications, which resolved after 2 weeks.The following device specifics were provided: lead model 3387, lead model 3389, ins model b35300r (summit rc+s).

• Brand Name: SUMMIT RC+S INS
• 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: 14402773
• MDR Text Key: 292610925
• Report Number: 2182207-2022-00790
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2022

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: B35300R
• Device Catalogue Number: B35300R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male