Patient and initial reporter information was not available.No parts were returned for product 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.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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Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that after insertion of the pedicle screws, it was confirmed that t9 left, t5 right, and t6 right were deviated from the spinal canal.The deviation was approximately 3 to 4mm.The screws were removed.The patient experienced paralysis of the right lower limb.The paralysis was not transient.The physician felt that the symptoms would recover to a certain extent, but will not completely recover.The case was completed with free hand.The surgeon felt that the paralysis was a result of the malfunction and the guidance system.The procedure was delayed less than an hour.
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