D10 concomitant product: fgs-0635 - fgs-0635 cf delivery dev caps bravo x5, lot# 60949f.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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According to the reporter, there are two capsules that successfully attached to the patient¿s esophagus but did not release from the delivery system.The first capsule did not break the handle upon failure to detached and tissue was tore.In the second capsule attachment, the handle spring broke when attempting deployment.The physician verified the capsule placement endoscopically and confirmed the capsules attached to the esophagus but would not release from the delivery system.Additional sedation was provided to the patient while recalibrating 2 more bravo capsules, (2 failed deployment).Third attempt was executed with a new lot number and was successful.The deployment device inserted with the capsule was facing the tongue and the entire device including the handle was maintained in the horizontal plane.The patient did not require unplanned hospitalization.The vacuum pump pressure reach 550 mmhg prior to placement and lubricant was carefully applied to avoid covering the suction chamber.There was no medical intervention performed for the tissue tear.
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