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

Model Number UNK_OARM_SYS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Confusion/ Disorientation (2553)

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

A1-a5) patient information was not included in the journal entry a2) this value reflects the mean age of the patients who underwent deep brain stimulation (dbs) implantation as specific patients could not be identified.A3) this value reflects the majority gender of the patients who underwent dbs implantation as specific patients could not be identified.B3) the article did not provide the date of the procedure.The event date provided is the published date.B5) the article citation is included.D4) the system product number and serial number were not provided in the journal article.Udi not available for this system.G2) no 510k provided as system is unknown.H3) no evaluation was performed as the event was reported as a literature article.H4) device manufacturing date is unavailable.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

Citation: kesarwani, r., mahajan, u.V., wang, a.S., kilbane, c., shaikh, a.G., miller, j.P., <(>&<)> sweet, j.A.(2024).Improved side-effect stimulation thresholds and postoperative transient confusion with asleep, image-guided deep brain stimulation.Operative neurosurgery.Https://doi.Org/10.1227/ons.0000000000001076 summary: background and objectives: asleep, image-guided deep brain stimulation (dbs) is a modern alternative to awake, microelectrode recording (mer) guidance.Studies demonstrate comparable efficacy and complications between techniques, although some report lower stimulation thresholds for side effects with image guidance.In addition, few studies directly compare the risk of postoperative transient confusion (ptc) across techniques.The purpose of this study was to compare clinical efficacy, stimulation thresholds for side effects, and rates of ptc with mer-guided dbs vs intraoperative 3d-fluoroscopy (i3d-f) guidance in parkinson¿s disease and essential tremor.Methods: consecutive patients from 2006 to 2021 were identified from the departmental database and grouped as having either mer-guided dbs or i3d-f¿guided dbs insertion.Directional leads were used once commercially available.Changes in unified parkinson¿s disease rating scale (updrs)-iii scores, levodopa equivalent daily dose, fahn¿tolosa¿ marin scores, and stimulation thresholds were assessed, as were rates of complications including ptc.Results: mer guidance was used to implant 487 electrodes (18 globus pallidus interna, gpi; 171 subthalamic nucleus; 76 ventrointermediate thalamus, vim) in 265 patients.I3d-f guidance was used in 167 electrodes (19 gpi; 25 subthalamic nucleus; 41 vim) in 85 patients.There were no significant differences in unified parkinson¿s disease rating iii scale, levodopa equivalent daily dose, or fahn¿tolosa¿marin between groups.Stimulation thresholds for side effects were higher with i3d-f guidance in the subthalamic nucleus (mer, 2.80 ma ± 0.98; i3d-f, 3.46 ma ± 0.92; p =.002) and vim (mer, 2.81 ma ± 1.00; i3d-f, 3.19 ma ± 1.03; p =.0018).Less ptc with i3d-f guidance (mer, 7.5%; i3d-f, 1.2%; p =.034) was also found.Conclusion: although clinical efficacy between mer-guided and i3d-f¿guided dbs was comparable, thresholds for stimulation side effects were higher with i3d-f guidance and the rate of ptc was lower.This suggests that image-guided dbs may affect long-term side effects and pose a decreased risk of ptc.Reported event: 1.350 patients with a history of essential tremor or parkinson's disease underwent deep brain stimulation (dbs) implantation.Surgical complication included a suboptimal position of the lead necessitating surgical revision.See attached literature article.

• Brand Name: O-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18845714
• MDR Text Key: 337855243
• Report Number: 3004785967-2024-00142
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/21/2024
• Initial Date FDA Received: 03/06/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male