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Model Number SDK4900-FT |
Device Problems
Migration or Expulsion of Device (1395); Application Program Problem (2880)
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Patient Problem
No Code Available (3191)
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Event Date 04/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during the procedure, the physician had issues deploying the fiducials, each one migrated upon deploying out of the end of the marker delivery kits.When tech was loading the fiducial into the first marker delivery kit it became lodged in the proximal hub and could not advance the guide wire.The superd portion was not completed.It was not completed by other means.The patient was under general anesthesia.
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Manufacturer Narrative
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the patient procedure was cancelled or aborted due to a system issue, and the fiducial marker migrated inside the patient.The reported issues could not be confirmed.The most likely root cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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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