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

Model Number 9735665

Device Problems Environmental Compatibility Problem (2929); Temperature Problem (3022); Excessive Heating (4030)

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

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

A manufacture representative went to the site to test the system.It was found that the system shut down occurred due to the battery pack overheating.The ups and battery pack were replaced.The system failed the system checkout due to the hardware failure of the system shut down.The battery measured 52.60v, upon return.The unit is currently undergoing bench testing, in conjunction with the accompanying ups.The returned ups is currently undergoing bench testing, along with the accompanying battery.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 sacroiliac and thoracolumbar procedure.It was reported that during a case the system spontaneously shut down.The surgeon had just finished placing the last screw and the navigation system was no longer needed.The manufacturer representative (rep) was on site and noticed that the battery was very hot to touch.The turned on the system and it spontaneously powered off again after 25 minutes.There was no impact to the patient and no procedure delay.Additional information was received from a company rep.Device information was provided.

Manufacturer Narrative

H3, h6: the battery(1832) was returned for product analysis.The battery measured 52.60v, upon return.The battery was tested overnight and caused the ups to shut down due to over heating.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 system was plugged into an outlet when it shut down on its own.

Manufacturer Narrative

H3, h6: the ups 9735787 main cart s8 svc (b)(4)) was returned for analysis.Analysis found that the ups was bench tested overnight, in conjunction with the accompanying battery.At some point overnight, the units powered down.Previous testing / experience has determined that the battery is normally the cause of the units powering down, as the battery overheats and subsequently the ups shuts off, as programmed to do.Otherwise; the all twelve and forty eight volt outputs measured normal voltage and the power switch functioned, as intended.No functional problem was found.The battery 9735773 48v s8 svc (b)(4)) has been returned to the manufacturer, however, analysis has not been completed.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 SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11204810
• MDR Text Key: 227950667
• Report Number: 1723170-2021-00173
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 01/12/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 01/20/2021; 02/08/2021
• Supplement Dates FDA Received: 02/03/2021; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 91