MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735665

Device Problem Imprecision (1307)

Patient Problems Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Iatrogenic Source (2498); Unspecified Nervous System Problem (4426)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

Udi not available for this system at time of filing.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation system.It was reported that there was inaccuracy during a sacroiliac and thoracolumbar procedure.For the procedure the surgeon was using the navigation system to navigate a pedicle access kit (pak) and a tap.The surgeon was also using a non-medtronic driver and screws which were placed without the use of the navigation system.It was stated that the surgeon ¿did not claim any issues with accuracy during surgery¿.The manufacturing representative that was present during the surgery stated that ¿he noticed visually that the tap trajectory appeared to be breaching the pedicel and asked the surgeon if they wanted to continue using that pathway and trajectory in which the surgeon stated yes¿.After the non-medtronic screws were placed the surgeon used a non-medtronic interbody with a medtronic navigated frame component tracker to place a non-medtronic implant.There was no delay to the surgery.It was reported approximately two weeks later the patient was claiming neurological deficits post-operatively following this procedure.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.Correction: product and related fields updated to proper value.

Manufacturer Narrative

A software analysis was initiated.The software analysis concluded that the software functioned as designed following review of the reported issue.

Event Description

Additional information was received.It was reported that the reported issue occurred in a minimally invasive l4,l5 and s1 pedicle screw insertion procedure.A transforaminal lumbar interbody fusion (tlif) was conducted on the l4-l5 and l5-s1 spaces.It was noted that there were difficulties with the pedicle screw projections, projections of the real-time placement and other surgical tools.Additionally, it was noted calibration errors occurred between the navigation system and medtronic imaging system.Post-operative, it was found that a pedicle screw was found to be placed sub-optimally at the l5 vertebrae.Additionally it was noted that the interbody cage was placed on multiple occasions.Due to the reported issue, it was indicated that the procedure was delayed multiple hours due to the reported issue.It was additionally noted by the physician that the sub-optimally placed screw was not known to have produced a neurological deficit via direct intra-operative observation of the spinal canal.Post-operative, during an examination in the recovery room found worsening lower extremity weakness, which was indicated to be decreased sensation in their distal left lower extremity with intact right lower extremity sensation by the physician,.One day post-operative, new left foot great toe weakness, ankle flexion/extension weakness and sensory decrease in an l5 and s1 distribution was discovered and deemed to be consist with post-operative inflammation and transient weakness often observed following procedures involving retraction of l5 and s1 nerve roots during decompression.A post-operative computed tomography (ct) scan found possible migration of the graft material and revision surgery was planned to prevent hardening of the graft and revision of the screw.On post-operative day 2, the physician elected to revise the screw placement, in addition to removing bone putty that had moved into the spinal canal.Following the revision procedure, it was noted that the patient could stand up bedside with a front wheel walker.It was later reported that the patient subsequently experienced irreversible paraplegia.

Manufacturer Narrative

H2) additional information: see b5 and associated coding updates.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.

• Brand Name: STEALTHSTATION S8 PREMIUM SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7560505
• MDR Text Key: 109774108
• Report Number: 1723170-2018-02395
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735665
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• 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): Other; Disability