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 Problem Visual Impairment (2138)

Event Date 03/23/2015

Event Type  Injury  

Manufacturer Narrative

Patient weight was reported as (b)(6).Please note that this date is based off of the date of publication of the article as the event date was not provided in the published literature.There was no allegation of malfunction of the system.Device lot number, or serial number, unavailable.Udi not available for this system at time of filing.The device was not returned, so no analysis was conducted.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 park, p.(2015).Three-dimensional computed tomography-based spinal navigation in minimally invasive lateral lumbar interbody fusion.Neurosurgery, 11, 259-267.Doi:10.1227/neu.0000000000000726.Background: as with most minimally invasive spine procedures, lateral lumbar interbody fusion (llif) requires the use of biplanar fluoroscopy for localization and safe interbody cage placement.Computed tomography (ct)-based intraoperative spinal navigation has been shown to be more effective than fluoroscopic guidance for posterior-based approaches such as pedicle screw instrumentation.However, the use of spinal navigation in llif has not been well studied.Objective: to present the technique for using an intraoperative cone-beam ct and image-guided navigation system in llif and to provide a preliminary analysis of outcomes.Methods: we retrospectively analyzed a prospectively acquired database and the electronic records of patients undergoing llif with spinal navigation.Eight patients were identified.Postoperative neurological deficits were recorded.All patients underwent postprocedural ct and x-ray imaging for analysis of accuracy of cage placement.Accuracy of cage placement was determined by location within the disk space.Results: the mean age was 66 years, and 6 patients were women.A mean 2.8 levels were treated with a total of 22 lateral cages implanted via navigation.All cages were placed within quarters 1 to 2 or 2 to 3, signifying the anterior half or middle portions of the disk space.There were no sensory or motor deficits postoperatively.Conclusion: use of an intraoperative cone-beam ct with an image-guided navigation system is feasible and safe and appears to be accurate, although a larger study is required to confirm these results.Reported event patient 5 ((b)(6) years old, male) with degenerative scoliosis had a normal neurological examination after surgery but later developed diplopia followed by weakness in all of his extremities.He was diagnosed with a miller-fisher variant of an acute inflammatory demyelinating polyradiculoneuropathy and was treated by plasmapheresis with subsequent complete resolution of symptoms.There was no reported allegation of malfunction of the imaging system.

• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8308316
• MDR Text Key: 135145945
• Report Number: 3004785967-2019-00195
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2019

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: 01/07/2019
• Initial Date FDA Received: 02/05/2019
• 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 Outcome(s): Other
• Patient Age: 65 YR