MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) MEDTRONIC NAVIGATION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number UNK_OARM_SYS

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient sex not available from the site.Patient weight not available from the site.Event date is the accepted date of the publication.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: catherine h.Moran, md, mariusz pietrzyk, phd, nagaraja sarangmat, md, carter s.Gerard, md, neil barua, phd, reiko ashida, md, alan whone, phd, konrad szewczyk-krolikowski, phd, lucy mooney, bsc, steven s.Gill, ms.Clinical outcome of "asleep" deep brain stimulation for parkinson disease using robot-assisted delivery and anatomic targeting of the subthalamic nucleus: a series of 152 patients.Neurosurgery, 2020.Doi:10.1093/neuros/nyaa367 abstract: background: recent advances in methods used for deep brain stimulation (dbs) include subthalamic nucleus electrode implantation in the ¿asleep¿ patient without the traditional use of microelectrode recordings or intraoperative test stimulation.Objective: to examine the clinical outcome of patients who have undergone ¿asleep¿ dbs for the treatment of parkinson disease using robot-assisted electrode delivery.Methods: this is a retrospective review of clinical outcomes of 152 consecutive patients.Their outcomes at 1 yr postimplantation are reported; these include unified parkinson¿s disease rating scale (updrs) assessment, tinetti mobility test, parkinson¿s disease questionnaire (pdq)-39 quality of life assessment, mattis dementia rating scale, beck depression inventory, and beck anxiety.We also report on a new parietal trajectory for electrode implantation.Results: a total of 152 patients underwent assessment at 1 yr.Updrs iii improved from 39 to 20.5 (47%, p <.001).The total updrs score improved from 67.6 to 36.4 (46%, p <.001).Updrs ii scores improved from 18.9 to 10.5 (44%, p <.001) and updrs iv scores improved from7.1 to 3.6 (49%, p<.001).There was a significant reduction in levodopa equivalent daily dose after surgery (mean: 35%, p <.001).Pdq-39 summary index improved by a mean of 7.1 points.There was no significant difference found in clinical outcomes between the frontal and parietal approaches.Conclusion: ¿asleep¿ robot-assisted dbs of the subthalamic nucleus demonstrates comparable outcomes with traditional techniques in the treatment of parkinson disease.Reported events: three patients experienced an infection requiring removal of the entire deep brain stimulation (dbs) system.Two superficial parenchymal intraoperative hemorrhages were reported to have occurred and were managed conservatively.One patient was noted to have required re-operation for evacuation of an ipg site hematoma.One patient was admitted for an overdose of prescription drug.One patient developed post-operative psychosis.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10924327
• MDR Text Key: 219179756
• Report Number: 3004785967-2020-01432
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2020

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: UNK_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 60 YR