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

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problem Tissue Damage (2104)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Patient weight is unavailable.No parts have been received by the manufacturer for evaluation.Concomitant medical products: other relevant device(s) are: product id: 29631, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system and automated trajectory guidance unit being used for a biopsy and catheter placement for a medtronic thermal therapy system procedure.It was reported that after drilling was completed for the automated trajectory guidance unit, the unit was removed for bolt insertion for the thermal therapy system.The alignment rod was removed, with noted resistance, and the bolt for the thermal therapy system was found to be out of alignment.The surgeon subsequently re-inserted the alignment rod and adjusted the bolt by twisting the unit.The bolt was moved about 2-3 millimeters off of the trajectory when the alignment rod was removed again.The facility then attempted to re-drill with the automated trajectory guidance unit and a separate bolt was used.No guide tubes were noted to be available for the guidance unit to accommodate the new handle.The new bolt did not move once the alignment rod was removed and the facility continued with the ablation on target.There was no reported impact on patient outcome.It was reported that protocol in the instructions for use (ifu) were not adhered to, resulting in the drilling issues and bolt placement for the thermal therapy system procedure.Additional information was received indicating that the facility was attempting to setup for the thermal therapy system workflow with the long drill guide.After drilling, it was reported that the user was too far from the desired location to use the biopsy needle to gather a sample.The automated trajectory guidance unit was then repositioned closer with the normal height guide.The surgeon then attempted to drill with the long drill guide and long drill bit.Subsequently a "squealing" noise was heard and the user stopped and switched to a short bit and drilled in the same hole.The user then repositioned back to the long guide workflow point and placed the bolt, where the friction was noted with the alignment rod and the hole was slightly larger.A separate bolt was used to place the cooling catheter system and the procedure was continued.

Event Description

Additional information was received.There was a reported delay to the procedure of five minutes due to this issue.There was no reported impact on patient outcome.

Manufacturer Narrative

H2) additional information: see b5.H3: a medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated and the navigation system functioned as designed.The system then passed the system checkout and was found to be fully functional.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): the logs and archive from the navigation system were returned to the manufacturer for evaluation.Analysis found that there was insufficient information to determine the relationship of the software to the anomaly.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 SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10593795
• MDR Text Key: 208789575
• Report Number: 1723170-2020-02542
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000272739
• UDI-Public: 00763000272739
• 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
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• 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: 10/13/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10".
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 45