Codman Certas Programmable Valves

Consumers and health professionals are advised that Johnson & Johnson Medical, in consultation with the TGA, has issued a hazard alert for the following two Codman Certas Programmable Valve products:

Codman Certas Programmable Valves are single-use implantable devices, designed to drain excess cerebrospinal fluid from the brain and carry it to other parts of the body for the treatment of hydrocephalus (also known as 'water on the brain'). The valves can be programmed to eight different settings.

Codman Certas Programmable Valves have a 'virtual off' setting, which limits flow through the valve.

In-house testing of the 'virtual off' setting by Johnson & Johnson Medical identified that, in one case involving a non-implanted device, the operating pressure for the valve fell significantly below the expected level. However, when retested, the valve performed at the expected pressure level.

If a valve is not operating at the expected pressure level while in the 'virtual off' setting, it could result in a delay in treatment in some circumstances.

Information for consumers

Please note that the above issue was identified through in-house testing by Johnson & Johnson Medical and was only found in one case involving a non-implanted device. Upon retesting, the affected valve performed at the expected pressure level.

There have been no reports of patients experiencing associated adverse events and the likelihood of a patient experiencing a problem as a result of this issue is very small.

Johnson & Johnson Medical has contacted the implanting surgeons and the hospitals where the devices have been implanted, providing further information regarding this issue, including advice on how to treat patients who have Codman Certas Programmable Valves.

If you or someone you care for has had a Codman Certas Programmable Valve implanted and has any questions or concerns, please contact your surgeon or the hospital where the device was implanted.

Information for all health professionals

If you are treating someone who has had a Codman Certas Programmable Valve implanted, reassure them that there have been no reports of patients experiencing associated adverse events and the likelihood of them experiencing a problem as a result of this issue is very small.

If they continue to have any questions or concerns about the above issue should be referred to the implanting surgeon or the hospital where the device was implanted.

Information for surgeons

Johnson & Johnson Medical has contacted the implanting surgeons and the hospitals where the devices have been implanted, providing further information regarding this issue, including advice on how to treat patients who have Codman Certas Programmable Valves.

If you are treating such a patient, you are advised:

• no action is required if your patient is experiencing good outcomes with an implanted valve
• be aware that symptoms resulting from this issue would be similar to those seen in the standard course of treatment, so it can be difficult to directly correlate complaints with this problem
• if the 'virtual off' setting is being used to address an acute overdrainage situation that has resulted in subdural haemorrhage or slit ventricle formation, you should closely observe the patient to ensure that they are responding as expected (with operating pressure greater than 400 mm H₂O).

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.