MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, SMALL, PERFORMANCE LEVEL 1.5; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	25131-5
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2018
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 the doctor was implanting the valve, and after implanting the catheters, they did the liquid drainage test with the valve, but they saw that the valve did not drain the liquid.The valve was never implanted, and the doctor decided to use a new valve which drained the liquid.The new valve was implanted, and the doctor closed the skin.There was no injury as a result of the event.The patient's medical history was congenital hydrocephalus.Their status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned valve was patent.It met requirements for leak, siphon, reflux, pressure flow, and pre-implantation testing.During flow testing, fluid was able to pass through the valve.Therefore, the complaint could not be duplicated by laboratory personnel.Particulates were noted on the interior of the valve.It is unknown how or when these particles entered the valve.The instructions for use cautions, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance (over-or- under drainage) of the shunt system¿¿ and ¿the system may become internally occluded due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris¿.All valves are 100% tested at time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DELTA SHUNT KIT, SMALL, PERFORMANCE LEVEL 1.5
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7971253
• Report Number: 2021898-2018-00500
• Device Sequence Number: 16447672
• Product Code: JXG
• UDI-Device Identifier: 00643169466425
• UDI-Public: 00643169466425
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 04/30/2022
• Device Model Number: 25131-5
• Device Catalogue Number: 25131-5
• Device Lot Number: E34268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Weight: 1