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

Model Number	92866
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
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 physician thought that the adjustment mechanism of the valve did not work properly.The adjustment tool showed a place between two performance levels.It was also stated that the valve did not drain cerebrospinal fluid properly, and the physician said that the valve was occluded.The device was explanted.The patient's medical history was operated hydrocephalus, and their status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for the valve flux, leak, reflux, pressure-flow, and preimplantation testing.The valve did not meet the requirements for siphon testing.The valve was returned with a performance level between 2.5 and 0.5.The laboratory personnel were able to adjust the setting to 0.5 and then to each performance level setting on the first attempt.There was proteinaceous debris on the interior and exterior of the valve.The instructions for use cautions, ¿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 II VALVE, REGULAR, WITH BIOGLIDE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8330951
• Report Number: 2021898-2019-00051
• Device Sequence Number: 11167694
• Product Code: JXG
• UDI-Device Identifier: 00643169976047
• UDI-Public: 00643169976047
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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: 10/31/2020
• Device Model Number: 92866
• Device Catalogue Number: 92866
• Device Lot Number: E40147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 04/04/2019
• 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: 84 YR