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

Catalog Number	44465
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	01/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product testing is in progress.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the device was removed as part of a shunt explant.According to the report, the patient was under follow-up.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for reflux, pressure-flow, and pre-implantation.Proteinaceous debris was noted within the interior and exterior of the valve.The instructions for use (ifu) that accompany the device caution that ¿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.¿ a review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC LP VALVE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6299076
• Report Number: 2021898-2017-00038
• Device Sequence Number: 16277938
• Product Code: JXG
• UDI-Device Identifier: 00643169466210
• UDI-Public: 00643169466210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 44465
• Device Lot Number: E06200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided; 02/22/2017
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 03/22/2017; 09/29/2017
• 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