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

Model Number	42866
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/26/2018
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 the patient was implanted in (b)(6) 2017 and had difficult hydrocephalus.Reportedly on 3-5 occasions, the patient had an mri and the valve setting was changed.Following the mri, the valve was reset to 0.5, but the patient developed significant hydrocephalus symptoms.It was noted the patient was in the intensive care unit for at least 1 instance.The symptoms would resolve after 2-3 days.It was stated the valve was tapped many times and the surgeon was wondering if there was any damage to the valve or debris within the valve that could have contributed to the hydrocephalus symptoms.The valve was explanted and the patient¿s status was noted as alive ¿ no injury.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for valve flux, siphon, reflux, pressure flow and pre-implantation testing.However, the valve did not meet the requirement for leak testing.There were several cuts observed on the dome and proteinaceous debris was observed within the interior and exterior of the valve.It is unknown how or when the damage to the dome occurred.The ifu states ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components¿.¿.The ifu also cautions that, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion or may also hold pressure/flow controlling mechanisms open, resulting in overdrainage¿.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
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7812296
• Report Number: 2021898-2018-00419
• Device Sequence Number: 13645709
• Product Code: JXG
• UDI-Device Identifier: 00613994804648
• UDI-Public: 00613994804648
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 11/30/2019
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: E23059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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; Life Threatening; Required Intervention