MAUDE Adverse Event Report: UNK CERTAS VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMP

Device Problem Programming Issue (3014)

Patient Problems Host-Tissue Reaction (1297); Headache (1880); Vertigo (2134)

Event Date 05/01/2013

Event Type  Injury  

Manufacturer Narrative

Udi: unknown part number, 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.

Event Description

Per phone call from patient's wife on 06april2016: it was reported that an unknown certas valve was implanted (b)(6) 2013.The valve was originally set to 4.The patient was not alert, unable to focus following procedure.Setting was then changed in (b)(6) 2013.Eventually set to 7.Patient then became alert.Condition improved.Patient in wheelchair and was experiencing veritgo, ears ringing, headaches.Ct scans consistent.Patient advocate reports that they could not find a surgeon/specialist to reprogram for three years.A nurse practioner at emory hospital turned to 'virtual off' and conditions immediately improved.The patient was no longer experiencing vertigo or headaches.Ears were still ringing.Shunt line is reported to be swollen and "burns".Patient looking to have shunt removed.

• Brand Name: UNK CERTAS VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMP
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6534625
• MDR Text Key: 74095765
• Report Number: 1226348-2017-10291
• 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 Family Member or Friend
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• 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: 04/06/2017
• 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