MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7¿; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9733856

Device Problem Imprecision (1307)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation system being used during a spinal procedure.It was reported that during a case with a long construct (two spin construct), the patient had moved.The site decided to take two additional spins, however, they found that these spins were inaccurate.They went back to the original two spins that they took and it was accurate.They did not confuse the first pair with the second pair of spins because the first pair of spins had a saved projection.They used the original spin to continue.The procedure was completed using the navigation system and there was no reported impact to patient outcome.There was a reported delay to the procedure of less than one hour due to this issue.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9733686.Software logs have been received by the manufacturer.However, analysis has not been completed at the time of the filing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9733686.Software logs have been received by the manufacturer.However, analysis has not been completed at the time of the 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 during a spinal procedure.It was reported that during a case with a long construct (two spin construct), the patient had moved.The site decided to take two additional spins, however, they found that these spins were inaccurate.They went back to the original two spins that they took and it was accurate.They did not confuse the first pair with the second pair of spins because the first pair of spins had a saved projection.They used the original spin to continue.The procedure was completed using the navigation system and there was no reported impact to patient outcome.There was a reported delay to the procedure of less than one hour due to this issue.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the issue could not be replicated.The navigation system then passed the system checkout and was found to be fully functional.H6: b01, c19, d14 apply to the system checkout.B21, c21 and d16 apply to the concomitant product.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

Additional information was received.It was reported that the degree of inaccuracy was greater than 3mm.

• Brand Name: STEALTHSTATION® S7¿
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12979544
• MDR Text Key: 285391838
• Report Number: 1723170-2021-02865
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• 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
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2015
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG