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

Model Number	42365
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2018
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 valve was ruptured intra-operatively.The valve was not implanted and the patient¿s status was listed as no injury.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for pressure-flow, and leak testing.However, the device did not meet the expectations for reflux, and pre-implantation testing.There was proteinaceous debris noted in the interior and exterior of the device.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve and may result in fluid reflux.The instructions for use (ifu) 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.¿ 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
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was clarified that the valve was tested after taking it out and water would not flow out of the pressure adjustment.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was clarified that the valve was tested after taking it out and water would flow out of the pressure adjustment.

• 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: 7212124
• Report Number: 2021898-2018-00037
• Device Sequence Number: 11009789
• Product Code: JXG
• UDI-Device Identifier: 00643169975804
• UDI-Public: 00643169975804
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/16/2018

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: 04/30/2022
• Device Model Number: 42365
• Device Catalogue Number: 42365
• Device Lot Number: E34229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/06/2018; 03/11/2018; 03/11/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 03/06/2018; 03/16/2018; 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR