Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Summary

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

Eligibility

Inclusion Criteria:

1. Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
2. Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves.
3. Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements.
4. For patients who have had the Codman CERTAS Plus Programmable Valve implanted prior to study enrollment, have available data from implantation to the current time.

Exclusion Criteria:

1. Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
2. Patient's planned shunt has distal drainage to the heart.
3. Patient has ventriculitis, peritonitis or meningitis.
4. Patient has sepsis.
5. Patient has a history of poor wound healing.
6. Patient has symptoms pertaining to a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this study.
7. Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant.
8. Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
9. Patient is currently enrolled in another drug or device trial or has been previously entered in this trial.
10. Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
11. Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. This criterion applies for patients to be treated with the BACTISEAL Catheters (included in some models of the valve) only.

Conditions8

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