MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF VENTRICULAR RESERVOIR, SIDE INLET, 18 MM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 44102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fever (1858); Vomiting (2144)

Event Date 10/15/2020

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 underwent implantation of an intracerebral ventrisculostomy (icv) set on (b)(6) 2019.On (b)(6) 2020, the patient initiated treatment with brineura (300 milligram, qow, icv).The most recent dose was administered on (b)(6) 2020.On (b)(6) 2020, before the infusion with brineura, the patient's cerebrospinal fluid (csf) cell count was measured and was normal with a value of 1 (units and reference range not reported).On (b)(6) 2020, the patient experienced fever and vomiting, and the number of csf cells increased to a value of 45, a grade 3 (pleocytosis), resulting in hospitalization.The investigator suspected bacterial meningitis and started administration of antibiotics (cefotaxime and vancomycin).On (b)(6) 2020, the fever disappeared and the number of csf cells decreased to a value of 11.In addition, a bacterial culture test was negative.Therefore, antibiotics were stopped on (b)(6) 2020.After that, the number of csf cells did not increase.No action was taken with brineura due to the event.The outcome of the event was reported as recovered/resolved on (b)(6) 2020.The investigator assessed the event of pleocytosis as related to treatment with brineura; therefore, this case qualifies for expedited reporting.The investigator assessed the event of pleocytosis as related to the icv device.According to the investigator, other etiological factors included the device or techniques.At the time of the event, the subject's vital signs were reported as: temperature (c): 38.9, respiratory rate (beath/min): 20, heart rate (bpm): 124, systolic blood pressure (mmhg): 108, diastolic blood pressure (mmhg): 75.And oxygen saturation (%): 98.On (b)(6) 2020, the patient had their icv device removed due to suspecteddevice-associated infection.

• Brand Name: CSF VENTRICULAR RESERVOIR, SIDE INLET, 18 MM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11666130
• MDR Text Key: 245426708
• Report Number: 2021898-2021-00093
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K833822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 44102
• Device Catalogue Number: 44102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2021
• 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: 5 YR
• Patient Weight: 21