MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR VALVE, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42955

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Swelling (2091); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had retained counsel who alleged a revision of the shunt was required.

Event Description

Additional information received reported that the patient was (b)(6) old when they were diagnosed with a rare form of brain cancer, an embryonal carcinoma.The patient started to experience nausea, vomiting, and lethargy, and they were immediately brought to the hospital emergency room (er) on (b)(6) 2016.The er doctors performed a ct scan that revealed a brain mass.At that time, due to concerns about hydrocephalus and the patient's increasing symptoms and changes in their heart rate, the doctor emergently placed an extraventricular drain.They were immediately transferred to the picu.About a week later, on (b)(6) 2017, the patient underwent removal of the external ventricular drain (evd) and placement of their shunt.Their medical team attempted to wean the patient from their evd resulted in leaking of fluid from around their evd and episodes of bradycardia.As a result, their care team decided to place a programmable shunt.Eventually, they were discharged on (b)(6) 2018.On (b)(6) 2017, the shunt appeared to be draining improperly, and the doctor adjusted the shunt from 1.0 to 0.5.2 days later, the patient was admitted to the hospital on (b)(6) 2017 for chemotherapy and to place a gastric tube.The parents had noted swelling around the shunt site.It was noted that the shunt reservoir depressed easily and refilled briskly.The fluid around the shunt was soft but did cause some floating of the shunt.Despite adjusting the shunt to the lowest setting of 0.5 and frequent pumping, the swelling/persistant fluid collection surrounding the valve continued.An mri on (b)(6) showed increased ventricle size secondary to valve settings.A shunt tap was performed and showed no infection, and it was easy to aspirate csf.The shunt was replaced on (b)(6) 2017.

Manufacturer Narrative

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

• Brand Name: STRATAMR VALVE, SMALL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7865611
• MDR Text Key: 119864998
• Report Number: 2021898-2018-00451
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K152700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 42955
• Device Catalogue Number: 42955
• Device Lot Number: E12753
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1702-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention