MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 25132-5

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during surgery, there was poor drainage with the valve.The valve was replaced and there was no injury to the patient.

Manufacturer Narrative

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

Event Description

Additional information received reported the cause of the poor drainage was not determined.

Manufacturer Narrative

The returned valve was patent.It met the requirements for siphon, reflux testing.However, it did not meet the requirements for pressure flow and pre-implantation testing.There was crystalline debris observed within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve.The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ the returned valve did not meet the requirements for leak testing due to a tear noted in the top of the delta chamber.It is unknown how or when this damage occurred.The instructions for use also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ it is also suggested that the valve be placed in a surgically created loose subgaleal pocket.This allows gentle placement of the valve and minimizes handling with surgical tools.All valves are 100% tested at the time of manufacture.Approximately 23 cm of the ventricular catheter was returned.It met the requirements for patency and leak testing.Approximately 90 cm of the peritoneal catheter was returned.It met the requirements for patency and leak testing.All catheters 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, REGULAR, PERFORMANCE LEVEL 1.5
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7063569
• MDR Text Key: 93371464
• Report Number: 2021898-2017-00604
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466418
• UDI-Public: 00643169466418
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K902783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 25132-5
• Device Catalogue Number: 25132-5
• Device Lot Number: D80028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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 Age: 52 YR
• Patient Weight: 76