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

Model Number	42355
Medical Device Problem Codes	Mechanics Altered (2984); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
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 during follow up, the patient's valve was found de-regulated.The patient had no symptoms, but the surgeon replaced the valve with a new one from another manufacturer.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the valve was found "instead of 1.5 to 2.0.".
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for reflux, leak testing, and valve flux test.However, the valve did not meet the requirements for pressure-flow and preimplantation.There was proteinaceous debris noted within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid reflux and affecting the flow of fluid through 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.¿ during the analysis process, laboratory personnel were able to adjust the performance level (pl) of the valve with the stratavarius unit.The complaint could not be duplicated because the pl did not readjust after it was set to a particular setting.There was damage/cut noted on the valve dome.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¿.¿.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
Information received stated that the patient was born with intra-abdominal bleeding.It was noted the deregulation was found without mri exposure.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information received clarified that the valve was found de-regulated twice, once on (b)(4) 2018 and another on (b)(4) 2018.The valve went from 1.5 which was the original adjustment to 2.0.

• Brand Name: STRATA NSC VALVE, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7915391
• Report Number: 2021898-2018-00474
• Device Sequence Number: 1514475
• Product Code: JXG
• UDI-Device Identifier: 00643169466920
• UDI-Public: 00643169466920
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K033850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/27/2019

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: 11/30/2021
• Device Model Number: 42355
• Device Catalogue Number: 42355
• Device Lot Number: E23053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 09/28/2018; 11/29/2018; 01/18/2019; 01/30/2019
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/05/2018; 12/06/2018; 01/22/2019; 02/27/2019
• 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: 11 MO