MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÀRL CODMAN CERTAS; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 82-8800PL

Device Problem Self-Activation or Keying (1557)

Patient Problem No Code Available (3191)

Event Date 12/08/2018

Event Type  malfunction  

Event Description

The patient had a progav shunt valve for vps.It was discovered that this valve changed setting on its own, without being programmed.We were also unable to re-program the valve in the clinical setting.It was concluded that valve was malfunctioning and patient was taken to the operating room to remove progav valve and exchange for a certas plus valve.

• Brand Name: CODMAN CERTAS
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÀRL; codman & shurtleff, inc.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8189267
• MDR Text Key: 131166993
• Report Number: 8189267
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704079002
• UDI-Public: (01)10886704079002
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 82-8800PL
• Device Catalogue Number: 828800PL
• Device Lot Number: 189922
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2018
• Type of Device Usage: N
• Patient Sequence Number: 1