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	12/12/2018
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 cracked during the procedure.There was no injury to the patient.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for reflux, valve flux test, pressure-flow, and preimplantation.The valve did not meet the requirements for leak or preimplantation testing.The valve failed leak testing due to tears between the dome and the proximal occluder.It is unknown how or when the damaged occurred.The ifu that accompanies the product cautions that, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components¿.¿.There was debris on the interior and exterior of the valve.The instructions for use (ifu) that accompany the device cautions that ¿ introduction of contaminant could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion.¿ 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: 8210450
• Report Number: 2021898-2019-00005
• Device Sequence Number: 1710182
• Product Code: JXG
• UDI-Device Identifier: 00643169975804
• UDI-Public: 00643169975804
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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: 04/30/2023
• Device Model Number: 42365
• Device Catalogue Number: 42365
• Device Lot Number: E46897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1