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 Infusion or Flow Problem (2964)

Patient Problem Fluid Discharge (2686)

Event Date 05/08/2020

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 with a diagnosis of hydrocephalus was taken to surgery on (b)(6) 2020 for placement of a ventric uloperitoneal shunt.On (b)(6) 2020, during touch time, the parents noted the dressing over the repair site to be saturated.The neurosurgery team was notified, and the patient was examined.Per notes, the shunt was tapped with 0.5 mls obtained; specimen was sent to lab for culture.The patient was taken to surgery on (b)(6) 2020 for removal of the previous ventriculoperitoneal shunt in it's entirety with replacement; lumbar myelomeningocele wound revision.Per operative note, upon removal of the reservoir of the old shunt, there was no flow from the proximal ventricular catheter.The distal system was interrogated, and there was intermittent distal flow.The patient remained in patient at the time of the report and per notes was doing well.

• Brand Name: CSF-FLOW CONTROL VALVE, CONTOURED REGULAR, MEDIUM PRESSURE
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 10105917
• MDR Text Key: 194128694
• Report Number: 2021898-2020-00155
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466944
• UDI-Public: 00643169466944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K841442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 42324
• Device Catalogue Number: 42324
• Device Lot Number: D66576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2020
• Date Device Manufactured: 09/10/2014
• 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: 21 DA
• Patient Weight: 3