Model Number S7 |
Device Problem
Imprecision (1307)
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Patient Problems
Infarction, Cerebral (1771); Spinal Column Injury (2081)
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Event Date 04/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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Patient information not provided due to japanese patient privacy regulations.Udi not available for this system at time of filing.Device manufacturing date is not available for this system at time of filing.No parts have been received by the manufacturer for evaluation.
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Event Description
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Medtronic received information regarding a navigation system being used in a cervical c5/6 (cervical laminoplasty) spine fusion procedure.It was reported that there was an alleged inaccuracy observed after the screw was inserted in the c5 on the left.3d images were taken with an imaging system and the issue had apparently resolved.However, it was reported that all the screws were inserted in the arterial ventricle at 50-70%.Surgical revision was required.On the second day post procedure, the patient experienced cardiopulmonary arrest as decreased blood flow caused the brain to swell and the brain stem to be pressed.The patient was revived and cerebral decompression was performed on the 3rd day post procedure.Blood was flowing from another vessel.The patient then reportedly fell down the stairs causing a cervical dislocation.A brain infarction occurred, however it was not known if it was due to the fall or the screws being inserted in the vertebral artery.
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Manufacturer Narrative
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Additional information: device manufacture date provided.
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Manufacturer Narrative
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A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that the system was performing as intended.The system passed the system checkout and was found to be fully functional.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 additional information that it was noted that a contributing factor to the issue was the movement of the reference frame.
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Search Alerts/Recalls
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