MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number 9735669 |
Device Problems
Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Information references the main component of the system.Other relevant device(s) are: product id: 9735736, software version #: (b)(4).Software logs have been received, but not analyzed.Codes b21, c21, and d16 are applicable.No other products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess).It was reported that after passing registration, the site received a 1.7mm metric, went to navigate, then returned and added a few trace patterns and then the model disappeared.They hit verify, then the screen went black and error message "system needs to restart." they rebooted system and the issue resolved.There was a reported delay to the procedure of less than one hour.There was no reported impact to the patient.
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Manufacturer Narrative
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H3: a medtronic representative went to the site to test the equipment.Testing revealed that the system performed as intended.The system then passed the system checkout and was found to be fully functional.B01, c19, d14 applicable codes h3: logs were received and analysis was found in sw- analysis determined it was confirmed that this was a known software anomaly.B01, c10, d02 applicable codes.Software version updated: 1.3.2 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.
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