MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, CONTOURED REGULAR, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42324
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	05/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 10105917
• Report Number: 2021898-2020-00155
• Device Sequence Number: 886744
• Product Code: JXG
• UDI-Device Identifier: 00643169466944
• UDI-Public: 00643169466944
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K841442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 21 DA
• Patient Weight: 3