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.

Manufacturer Narrative

The returned valve was patent.The valve met the requirements for leak, siphon, and reflux.The valve did not meet the requirements for pressure-flow and preimplantation testing.Biological debris was observed on the interior of the valve.The instructions for use cautions, ¿shunt obstruction may occur in any of the components of the shunt system.The system may become internally occluded due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris.¿ all valves are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• 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: 9293236
• MDR Text Key: 165566413
• Report Number: 2021898-2019-00400
• 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,Followup
• Report Date: 12/26/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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