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

Model Number	44420
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the valve had poor elasticity.It was stated the reservoir rebound speed was slow during the pre-operative test.After implantation, no function was found.The valve was explanted and replaced.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned valve had catheters connected to the inlet and outlet connectors with sutures.The valve was occluded and the laboratory technician could not adjust the performance level setting.The valve was flushed, and water was able to flow through the valve.The laboratory technician was not able to adjust the performance level setting after flushing either.Therefore, the valve could not be tested for patency, leakage, valve flux, reflux, siphon, pressure-flow and preimplantation.There was proteinaceous debris on the exterior and interior of the valve.The instructions for use cautions, ¿underdrainage may occur due to obstruction or inadequate performance level setting.Shunt obstruction may occur in any of the components of the shunt system due to plugging by brain fragments, blood clots, bacterial colonization, tumor cell aggregates or other debris at some point along its course.¿ 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 LUMBOPERITONEAL SHUNT KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8423164
• Report Number: 2021898-2019-00103
• Device Sequence Number: 2170196
• Product Code: JXG
• UDI-Device Identifier: 00643169975866
• UDI-Public: 00643169975866
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 44420
• Device Catalogue Number: 44420
• Device Lot Number: E53624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 32 YR