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

Model Number	92856
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was replaced the day prior because for the last approximately 18 months, the device's pressure setting had changed spontaneously 3 times.It was noted the patient was implanted for cerebral pares and hydrocephalus.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned valve was patent.All performance levels could be set with a single attempt, and the valve did not spontaneously change levels during the course of analysis.Therefore the conditions of this complaint could not be verified by laboratory personnel.The valve also met the requirements for siphon, pressure flow, preimplantation and leak testing.However it did not meet the requirements for reflux testing.Proteinaceous debris was observed in the interior and on the exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid reflux.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.¿ 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, SMALL, 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: 6937609
• Report Number: 2021898-2017-00511
• Device Sequence Number: 1324443
• Product Code: JXG
• UDI-Device Identifier: 00643169010420
• UDI-Public: 00643169010420
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 92856
• Device Catalogue Number: 92856
• Device Lot Number: D57285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 12/20/2017
• 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
• Patient Age: 7 YR