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

Catalog Number	42365
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for reflux, pressure-flow, pre-implantation.Proteinaceous debris was noted within the interior and exterior of the valve.The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris¿.The valve did not meet the requirements for leak testing due to a tear in the top of the cassette housing chamber.It is unknown how or when this damage occurred.The instructions for use that accompany the device 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.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the reservoir leaked during pre-implantation testing.According to the report, the procedure was completed using another device.Reportedly, there was no injury to the patient.

• Brand Name: STRATA NSC VALVE, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6395023
• Report Number: 2021898-2017-00105
• Device Sequence Number: 48030
• Product Code: JXG
• UDI-Device Identifier: 00643169466111
• UDI-Public: 00643169466111
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K033850
• 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
• Report Date (Section B): 02/10/2017

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: 09/30/2021
• Device Catalogue Number: 42365
• Device Lot Number: E18938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1