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

Model Number	42365
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
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 when the doctor inspected the valve during the operation, they found that the reservoir was leaking.The procedure was completed with backup products, and it extended the procedure by 10 minutes.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for reflux, valve flux test, pressure-flow, and preimplantation testing.There was a small piece of the catheter attached to the inlet connector.The valve did not meet the requirement for leak testing due to a tear between the reservoir and the proximal occluder.It is unknown how or when the damaged 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¿.¿.There was proteinaceous debris observed on the interior and exterior of the valve.The instructions for use cautions, ¿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.

• 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: 8518732
• Report Number: 2021898-2019-00150
• Device Sequence Number: 1840057
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: 12/31/2022
• Device Model Number: 42365
• Device Catalogue Number: 42365
• Device Lot Number: E41888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR