MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II VALVE, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42856
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the surgery, the doctor found a small hole in the valve.The valve was replaced with another one of the same model.It was noted that this resulted in a 60 minute delay in the procedure.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned valve met the requirements for patency, valve flux, and preimplantation testing.The valve did not meet the requirements for leak, reflux, siphon, and pressure/flow testing.A segment of catheter was connected to the outlet connector with a suture.A tear was observed on the casing of the delta chamber.It is unknown how or when this damage occurred.The instructions for use cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity¿¿ biological debris were observed on the valve.The instructions for use cautions, ¿shunt obstruction may occur in any of the components of the shunt systems.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris.¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received reported that there were no environmental/external/patient factors that may have led or contributed to the issue.

• Brand Name: STRATA II VALVE, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9349024
• Report Number: 2021898-2019-00415
• Device Sequence Number: 2739912
• Product Code: JXG
• UDI-Device Identifier: 00643169975828
• UDI-Public: 00643169975828
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 42856
• Device Catalogue Number: 42856
• Device Lot Number: E41995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/22/2019; 12/16/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/02/2019; 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 11