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

Model Number 42365

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Headache (1880); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2018

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's valve was implanted on (b)(6) 2018, but had to be removed on (b)(6) 2018 because it was not working.It was noted that it would not do anything so the customer believed there was some type of malfunction going on.

Manufacturer Narrative

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

Event Description

Additional information received reported that there was a shunt valve malfunction.The patient's headaches had returned, and the surgeon was unable to interrogate the shunt.The shunt valve was attempted to be interrogated, but there was no current reading on it.The surgeon determined the valve was nonfunctional and recommended a revision of the shunt.It was stated the valve was implant on (b)(6) 2018 and explanted on (b)(6) 2018.Therefore, it is unclear when the device was implanted and explanted due to conflicting information being reported.

Manufacturer Narrative

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

Event Description

Additional information received reported that it was confirmed that the patient was implanted on (b)(6) 2018 as a cystoperitoneal shunt placement, laparoscopic and explanted on (b)(6) 2018 where the shunt valve was replaced and a revision of the proximal catheter.The patient was discharged home on (b)(6) 2018.It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.

Manufacturer Narrative

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

Manufacturer Narrative

The returned valve had a blue tint that is possibly due to fluid in the specimen container.It met the requirements for patency, reflux, leak testing, and valve flux test.However, the valve did not meet the requirements for pressure-flow and preimplantation.There was proteinaceous debris noted within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid reflux and affecting the flow of fluid through the valve.The instructions for use (ifu) that accompany the device cautions that ¿introduction of contaminant could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion.¿ there was damage noted on the valve flange.It is unknown how or when the damaged occurred.The ifu that accompanies the product cautions that, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components¿.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 NSC VALVE, REGULAR
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7655381
• MDR Text Key: 112908486
• Report Number: 2021898-2018-00314
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42365
• Device Catalogue Number: 42365
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• 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
• Patient Age: 44 YR
• Patient Weight: 88