MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL SHUNT KIT BURR HOLE, 16 MM, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Model Number 9040 E |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during the procedure, the surgeon decided that the valve was not draining cerebrospinal fluid.As a result, they opened up a new package and used it.The patient's status at the time of the report was alive-no injury.
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Manufacturer Narrative
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The returned device was patent.The valve passed reflux testing.The valve did not pass leakage, pressure flow and preimplantation testing due to a hole present on the flange of the reservoir of the valve.It cannot be determined how this damage may have occurred.Instructions for use states that, ¿use of sharp instruments while handling these devices can nick or cut the silicone elastomer, resulting in leakage and necessitating shunt revision.¿ dhr review of lot # e45235 did not indicate any findings that correlate with the complaint.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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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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Event Description
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Additional information received reported that there were no environmental/external/patient factors that may have led or contributed to the issue as they were not expected since the event occurred during the surgery.
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Search Alerts/Recalls
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