Evaluation summary: medtronic conducted an investigation based upon all information received.The capsule and delivery device were returned for evaluation.Visual inspection identified the delivery device was broken.Functional evaluation of the device found the plunger was not connected to the handle.It was reported that the capsule failed to attach to the patient's esophagus.A related device issue could not be confirmed.The product analysis noted evidence that the device was not used as intended; the handle was turned more than 1/8 of a turn.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that products meet all medtronic quality specifications.The instructions for use included with this device provide the following guidance: swiftly press the plunger on top of the handle all the way down until it stops at its locking position.Using your thumb, rotate the plunger from the side one-eighth (1/8) of a turn clockwise to release the capsule from the delivery device.The plunger springs up so that a white line is visible on the sixth rib of the plunger.Warning: pressing down on the plunger too slowly may result in the capsule not properly attaching to the patient¿s esophagus or not detaching from the delivery device.Do not rotate the plunger while depressing it.Do not rotate or otherwise force the plunger beyond the white line on the barrel.Rotating or forcing the plunger beyond this may result in possible damage to the delivery device.This may also interfere with the detachment of the capsule from the delivery device, and cause possible injury to the patient.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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