Model Number BI70002000 |
Device Problem
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 12/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: bi71000450, serial/lot: unknown.The surgeon's name has been requested.Patient information has been requested.A medtronic representative went to the site to perform a system check out and they found multiple errors regarding a low voltage power supply being out of specifications.The +5vdc measured at 4.82vdc.The manufacturer representative increased ps1 output to 5.12vdc, but the output consistently fluctuated during measurement.The cause was determined to be an unstable ps1 power supply.The ps1 was replaced to resolve the issue.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 an imaging system being used during a spinal procedure.It was reported that the initial spin stopped half way through and provided a warning stating that the spin was interrupted.The site rebooted the system two time before they were able to proceed with the case.There was no patient harm.
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Manufacturer Narrative
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A2-a5: patient information updated.H3, h6: the kit svc o2 bi71000450 power supply psi (rev.2 : s/n (b)(6) ) was returned for analysis.Analysis confirmed the complaint.The ps1 power supply failed bench testing.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.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.It was reported that the system was being used for a revision si fusion procedure and was rebooted 2 times before operating correctly.There was a longer anesthesia time and there was a 20-30 minutes surgical delay.
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Manufacturer Narrative
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Per (b)(4), it was determined there was an accidental radiation occurrence due to early termination of acquisition.No defect in an electronic product or failure to comply per 21 cfr 1003 was discovered.The investigation concluded that the issue was due to hardware.Ps1 power supply component replaced to resolve.Estimated absorbed or effective dose information is not available.Estimated absorbed dose to patient based on unutilized radiation is = 12.5 msv.Number of people exposed:1 - patient total number of people in room - 8 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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Search Alerts/Recalls
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