A Study on the Safety of Hakim Programmable Shunt System

A Multi-center, Retrospective Registry Study on the Safety of Hakim Programmable Shunt System

This study aimed to collect safety information from subjects implanted with a shunt system (trade name: Hakim Shunt Programmable System) produced by Codman & Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.

Inclusion Criteria:

1. The informed consent was exempted by the Ethics Committee of a research center. Either a subject or his/her legal representative signed the informed consent form (ICF) prior to enrollment.
2. Subject had an indication suitable to use Hakim Shunt Programmable System.
3. Subject received a Hakim Shunt Programmable System at least one year ago.

Exclusion Criteria:

1. Subject didn't have an indication suitable to use the product.
2. Subject was known to be allergic to a component or ingredient of the product to be implanted, including silicone tubing and other components.
3. According to the comprehensive judgment of an investigator, subject had an infection of the implant site when the shunt system was implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
4. Subject was simultaneously implanted with another shunt system different from Hakim Shunt Programmable System.
5. Subject had a contraindication of the shunt operation.
6. Subject had uncorrected coagulopathy or any bleeding disorder.