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

Model Number 42866

Device Problems Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient was implanted in (b)(6) 2018.The patient had enlarged ventricles and the valve setting was set to 0.5.Two days after implant, the patient was scanned and it was noticed that overdrainage occurred and the ventricles were constricted.The valve setting was adjusted to 1.5, however the ventricles enlarged once more after the patient was scanned two days later.The valve was adjusted to 1.0 and ventricles constricted again.A second doctor was called in to identify the cause of the underdrainage and overdrainage.The doctor noted that upon adjustment, the new adjusted pressure setting did not reflect the change, rather it still displayed the older setting.As the patient¿s condition was deteriorating, the doctor replaced the valve in (b)(6).The patient was doing well with the new valve.Following the explant, the old valve did not seem able to change settings when using both the handtools and stratavarius.

Manufacturer Narrative

The returned valve was patent.It met the requirements for valve flux, siphon, reflux, pressure-flow, and pre-implantation testing.The performance level setting was adjustable with both the handtools and the stratavarius.Therefore, the nature of the complaint could not be replicated by laboratory personnel.The valve did not pass leak testing due to a tear in the dome.It is unknown how or when the damage to the casing occurred.The ifu cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of component.Such damage may lead to loss of shunt integrity.¿ there was debris on the interior of the valve.The ifu 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
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8201280
• MDR Text Key: 131583332
• Report Number: 2021898-2018-00594
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: E45681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention