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

Model Number	42312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	06/10/2017
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 on (b)(6) 2017, the patient was admitted to the hospital for a wound leak at the surgical site.The doctor repaired the surgical incision.It was noted the wound was oversewn with 3-0 monocryl at the patient's bedside after local injection.It was also stated that there was a slight worsening of hydrocephalus; however, there was no evidence of shunt malfunction.The patient was released the following day, and the parents were instructed to a pump regimen of 10 times every 2 hours.

• Brand Name: CSF-FLOW CONTROL VALVE, CONTOURED SMALL, LOW
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8636152
• Report Number: 2021898-2019-00192
• Device Sequence Number: 1821624
• Product Code: JXG
• UDI-Device Identifier: 00643169466494
• UDI-Public: 00643169466494
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K841442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 42312
• Device Catalogue Number: 42312
• Device Lot Number: D80703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/23/2019
• 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: 10 MO