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Model Number 9735602 |
Device Problems
Application Program Problem (2880); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9731203, ubd: unknown, udi#: unknown.H6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 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 being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the break out box (bob) was not communicating while in surgery.The bob and emitter initially showed as connected in the equipment setup screen, but the emitter details showed an "unable to read port" status message in the emitter details.Then the emitter began showing as not connected.The status on the back of the bob appeared to be a 7.The local representative (rep) tried changing the power outlets the bob was connected to, swapping emitter ports on bottom of the bob, and reseating the communication cable between bob and monitor with no change in symptoms.The site swapped usb ports on the computer with no change as well.There was no apparent physical damage to bob communication cable.Delay and patient impact information were unknown.Additional information was received.It was reported that it was confirmed that when using a known working emitter on the system with the original bob and bob communication cable, the symptoms resolved.
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Manufacturer Narrative
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H3, h6: a medtronic representative went to the site to test the equipment.Testing revealed that there was a communication error.The axiem communication cable and emitter were replaced to resolve this issue.Codes b01, c07 and d02 are applicable to this analysis.The field generator, lot number: 0400002340, was returned to the manufacturer for analysis.The housing on the returned field generator is damaged / cracked.Otherwise; the unit functioned, as intended.Codes b01, c07 and d02 are applicable to this analysis.Code g04070 is applicable to this product.The cable, lot number: 190813, was returned to the manufacturer for analysis.The cable was found to be fully functional with no problem found.The returned cable passed a continuity test with no opens or shorts detected.The reported event could not be duplicated by medtronic personnel.Codes b01, c19 and d14 are applicable to this analysis.Additional information in b5.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id 9735546.Code g02004 is applicable to this product.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 there was no delay and no impact on patient outcome.
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Search Alerts/Recalls
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