MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, CONTOURED REGULAR, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42324

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Loss of consciousness (2418)

Event Date 10/23/2019

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 admitted to the clinic in an emergency due to disturbances of consciousness with suspicion of vp shunt malfunction.It was stated the valve had no outflow of liquid.The valve was explanted and replaced with another manufacturer's valve.The patient's status was alive-no injury.

Manufacturer Narrative

The returned valve was patent.The valve met the requirements for reflux and preimplantation testing.The valve did not meet the requirements for leak and pressure/flow testing.Damage was observed to the outlet connector.It is unknown how this damage occurred.The instruction for use cautions, ¿improper handling or use of instruments when implanting shunt products may result in the cutting, slitting, crushing or breaking of components.Such damage may lead to a loss of shunt integrity¿¿ debris was observed on the exterior and interior of the valve.The instruction for use, ¿shunt obstruction may occur in any of the components of the shunt system.¿ 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: CSF-FLOW CONTROL VALVE, CONTOURED REGULAR, MEDIUM PRESSURE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 9246867
• MDR Text Key: 170702471
• Report Number: 2021898-2019-00388
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K841442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42324
• Device Catalogue Number: 42324
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention