MAUDE Adverse Event Report: MEDTRONIC DOMINICANA DELTA VALVE, SMALL, PERFORMANCE LEVEL 1.0; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42812

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Headache (1880); Nausea (1970); Visual Impairment (2138); Vomiting (2144); Dizziness (2194)

Event Date 01/15/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information regarding a valve.It was reported the patient went to see the doctor in mid january, and they did have complaints of mainly left-sided and some degree of dizziness.However, the patient returned in late january with severe, unremitting headache, nausea, and vomiting as well as visual complaints.Ultimately, they felt like their shunt was working.However, the patient's ventricles on successive imaging studies got bigger, particularly in the fourth ventricle, with some mild mass effect on the brainstem and a small amount of trans ependymal flow.Thus, in the light of the fact that they considered the patient to have a functioning shunt, they placed a right external ventricular drain to get a better sense of what their pressures were.Despite the pressures being completely in the normal range with a single-digit intracranial pressures or even negative intracranial pressures, their headaches had subjectively not improved significantly, although they had some improvement in their nausea and vomiting.More recently, in a delayed fashion, their shunt tap that was done in the clinic from her existing left shunt system grew back bacillus in just the broth, and then a subsequent cerebrospinal fluid (csf) culture that was when their new external ventricular drain (evd) was placed grew back p.Acnes.Thus, the entire shunt system on the left side was removed, and the right side evd was replaced.The patient had also been on linezolid since the evd went in.

• Brand Name: DELTA VALVE, SMALL, PERFORMANCE LEVEL 1.0
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18946119
• MDR Text Key: 338185521
• Report Number: 9612501-2024-00805
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42812
• Device Catalogue Number: 42812
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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