MAUDE Adverse Event Report: CODMAN CERTAS PLUS; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unknown product code, udi unavailable.It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time, this complaint is considered closed.Device not available.

Event Description

As reported by the patient: "i had a shunt put in my head (b)(6) 2015, and i recently went back due to a valve malfunction and had surgery to replace valve on (b)(6) 2015.I'm wondering if there have been any recent issues with the valve in this shunt? any information would greatly be appreciated.".

Manufacturer Narrative

Additional event information was received from the patient on 03 aug 2017.This report has been updated to reflect that information.While no product information has been provided and the device has not been returned, additional attempts to obtain this information can now be undertaken with the facility information provided by the customer.A follow-up report will be submitted upon completion of the investigation.

Event Description

As reported by the patient: customer reported that a certas plus valve was implanted in (b)(6) 2016.Patient reported experiencing headaches in (b)(6) 2017.It was suspected that the csf was not draining.A lumbar puncture was performed on (b)(6) 2017.Symptoms subsided after procedure.Valve was revised and replaced with another valve on (b)(6) 2017.Patient reports ongoing headaches.

Manufacturer Narrative

The surgeon was contacted and reported that the device was revised; however, no specific device failure was reported.The surgeon also reported that it was unknown whether the valve was retained.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CODMAN CERTAS PLUS
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6754210
• MDR Text Key: 81412020
• Report Number: 1226348-2017-10530
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention