MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problems Tissue Damage (2104); Numbness (2415); Spinal Cord Injury (2432)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

Patient age and weight unavailable at time of filing.Concomitant medical products: other relevant device(s) are: product id: 9735740, serial/lot #: version: 1.2.0.No device evaluation has been performed at the time of filing.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure.It was reported that the site had an alleged inaccuracy when placing 4 screws.The site had completed a medtronic imaging system auto-registration and placed the four screws.When confirming placement, the site found that the screws were in the spinal canal.It was unknown how the site confirmed placement.The surgeon had removed the screws, aborted navigation, and completed the case with a c-arm.Additional information was received from the manufacturer representative indicating that after completing a test spin with the medtronic imaging system, the system was 1 inch inaccurate.It was also noted that the site had a lead lined shield in between the imaging system and the navigation system camera.After the shield was removed, the inaccuracy was corrected and the imaging system spin was accurate.It was not known if the shield was present during the case and could have caused the inaccuracy.It was also reported that the surgeon did not check known anatomical landmarks before navigating, but when on bone the navigation showed the instrument on bone.After the case, the manufacturer representative had the surgeon check the perc pin for stability and the surgeon stated it felt secure.There was a less than 1 hour delay to the procedure and the patient was affected.

Event Description

Additional information was provided stating that the site was using spinous process clamp not the perc pin.The clamp was 6 levels away from the clamp at the time of the inaccuracy.

Manufacturer Narrative

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.

Event Description

Additional information was provided stating that the misplaced screws were due to the technique used by the resident physician.The patient lost motor function within the operating room.Post-operatively the patient regained feelings in both legs.

Manufacturer Narrative

B5: additional information provided.D10: software logs were returned for evaluation.Software analysis has not been completed at the time of this report.H3, h6: a medtronic representative went to the site to perform a system checkout.The system passed checkout and no parts were replaced.H6: patient codes updated based on additional information.Fdm 10, fdr 213, fdc 67 are applicable to the system checkout.Fdm 4118, fdr 3233, and fdc 11 are applicable to software analysis.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.

Manufacturer Narrative

H3, h6: software analysis confirmed that the software functioned as designed.Per the system checkout, a lead shield was positioned between the navigation and imaging system.The system checkout completed successfully once the shield was removed.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.

• Brand Name: STEALTHSTATION S8 PREMIUM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10083649
• MDR Text Key: 191858602
• Report Number: 1723170-2020-01493
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 79