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

Model Number 9735665

Device Problems Environmental Compatibility Problem (2929); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9735773, serial/lot #: unknown.Product id: 9735787, serial/lot #: unknown.The ups and battery are pending replacement.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the site's camera cart spontaneously shut down prior to a case.The manufacturer representative booted the system up and the behavior continued three times, allowing the representative to enter the application, but after 15 minutes the camera cart would power off.There was no blue led on the power button.The self-test tool stated that the connection with the uninterruptible power supply(ups) was lost.The manufacturer representative tried a different interconnect cable and the power behavior still persisted.Another system was brought in to start the case.The representative called technical services after the third shutdown to attempt troubleshooting.In the admin application with the self-test tool open, the camera cart ups connection was listed as lost and the main cart ups was connected, but the battery was flickering between 0% and 100%.Technical services recommended checking the indicator lights on the ups of the camera cart, but no lights were present.Technical services then recommended to discharge the ups and unplug it from wall power.Upon boot up, the main and camera cart powered on.The ups on the camera cart had led indicator lights up, and the self-test tool showed that the ups of the main and camera cart were connected and at 100%.The manufacture representative removed the carts from wall power, and the main cart had a 95% charge with 18 minutes remaining and the camera cart had 95% charge with 19 minutes remaining.Technical services remained on the line for two minutes and the values did not drop.Technical services recommended a software shutdown to ensure the issue was resolved.The batteries and power supplies were functioning as intended.It was later reported that the system's main cart had powered off spontaneously twice since the site discharged the ups.This occurred while the system was idle and plugged into a wall outlet.The system will idle for about 15 minutes, before the main cart spontaneously powers off.The camera cart remains powered on.The manufacturer representative checked the ups in both carts, and found that right before powering off the main cart battery charge was fluctuating from 0% to 100%, flickering back and forth.The main cart ups has a flashing amber battery led and the v2 led was not lit up.All other leds were green, and eventually the v2 led became green.The camera cart ups had a green e-net led and the battering indicator was flashing amber.The main cart battery seemed to get hot to the touch, whereas the camera cart battery did not.Technical services recommended unplugging the main cart battery from the ups until the ups and battery can be replaced.The representative was instructed to leave the unit idle on the wall power with the main cart battery disconnected to see if the spontaneous power issue persists.There was no patient involvement.

Manufacturer Narrative

D11 additional information: lot numbers of concomitant products 9735773 and 9735787 are 1924 and 19180095, respectively.H3) a medtronic representative went to the site to test the equipment.The uninterruptible power supply (ups) and battery were replaced.The system then passed a system checkout.The battery was returned to medtronic for analysis.Analysis revealed that during overnight testing, the battery overheated and caused the ups to power off.An electrical failure was confirmed.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.The ups was also returned to medtronic for analysis.Analysis revealed that the returned ups powered down sometime overnight during testing.Otherwise, all outputs measured normal voltage.An electrical failure was confirmed.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.H6) fdm 10, fdr 120, fdc 4307 are applicable to the system checkout and ups/battery 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.

• 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: 10454857
• MDR Text Key: 204416877
• Report Number: 1723170-2020-02278
• 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
• Report Date: 09/14/2020

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: 09/08/2020
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1