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

Model Number	42823
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-implantation patency testing, there was saline leaking from the top of the delta chamber of the valve.The valve was to be replaced and there was no injury to the patient.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for siphon, reflux, pressure flow and preimplantation testing.Proteinaceous debris was observed in the interior and on the exterior of the valve.The returned valve did not meet the requirements for leak testing due to a tear noted in the top of the delta chamber.It is unknown how or when this damage occurred.The instructions for use also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ it is also suggested that the valve be placed in a surgically created loose subgaleal pocket.This allows gentle placement of the valve and minimizes handling with surgical tools.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DELTA VALVE, REGULAR, 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: 7062053
• Report Number: 2021898-2017-00599
• Device Sequence Number: 13932257
• Product Code: JXG
• UDI-Device Identifier: 00643169466852
• UDI-Public: 00643169466852
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: 11/30/2021
• Device Model Number: 42823
• Device Catalogue Number: 42823
• Device Lot Number: E23767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1