MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, SMALL PERFORMANCE LEVEL 2.0; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 25131-2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that after 2 weeks of shunt installation, the valve was not working properly.It was stated that it stopped working with pressure 140-160, but only up to 170.The valve was explanted and replaced with another valve.The patient was implanted for triventricular hydrocephalus.

• Brand Name: DELTA SHUNT KIT, SMALL PERFORMANCE LEVEL 2.0
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 9293247
• MDR Text Key: 165548897
• Report Number: 2021898-2019-00401
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169472778
• UDI-Public: 00643169472778
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K902783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 25131-2
• Device Catalogue Number: 25131-2
• Device Lot Number: E09997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/07/2019
• Date Device Manufactured: 03/23/2016
• 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: 3 MO
• Patient Weight: 4