MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, BURR HOLE, 16MM, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42544

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that prior to the procedure, the physician found there was a ¿pressure problem.¿ the valve was to be replaced and there was no injury to the patient.

Manufacturer Narrative

The returned valve was patent and met the requirements for reflux and leak testing.However, the valve did not meet the requirements for pressure-flow and preimplantation testing.There was proteinaceous debris on the interior of the valve.The instructions for use cautions, ¿care must be taken to ensure that p articulate contaminants are not introduced into shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance (overdrainage or underdrainage) of the shunt system.Particulate matter, which enters the shunt system, may also hold pressure/flow controlling mechanisms open, resulting in overdrainage.¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information received reported that the physician tested the shunt pressure before implantation, and they couldn't get a normal pressure.

• Brand Name: CSF-FLOW CONTROL VALVE, BURR HOLE, 16MM, MEDIUM PRESSURE
• 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: 8200292
• MDR Text Key: 131533500
• Report Number: 2021898-2018-00588
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466913
• UDI-Public: 00643169466913
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K831678
• 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,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 42544
• Device Catalogue Number: 42544
• Device Lot Number: E42551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 02/12/2019; 03/20/2019
• Supplement Dates FDA Received: 03/06/2019; 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2018
• 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