MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number 9735665 |
Device Problems
Imprecision (1307); Device Sensing Problem (2917); Data Problem (3196)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9735737, serial/lot #: (b)(4).A medtronic representative went to the site to test the equipment.Testing revealed that there was no fault found.The imaging system then passed the system checkout and was found to be fully functional.Codes b01,c19,d14 are applicable.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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Event Description
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Medtronic received information regarding a navigation system.It was reported that during a case, the system was unable to navigate using the pointer.The site was able to register and verify the instruments properly but when trying to navigate using a different navigation system, the brain did not show up on the screen.The site then loaded their plans onto this current navigation system and the issue continued.The use of navigation and imaging were aborted.There was a patient involved.(b)(6) 2022 (rep): additional information was received, the patient demographics were provided.(b)(6) 2022(rep): additional information was received, it was reported that there was a 10 minute delay due to the issue and the use of navigation was aborted.The procedure type was also a cranial tumor resection.
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Manufacturer Narrative
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H2/h3: software analysis was performed.The analysis determined that there is information insufficient to determine the root cause of the reported issue.Codes b01, c19, and d15 are applicable to this 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.
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Event Description
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Additional information was received, the surgical delay was the only impact to the patient.
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