MAUDE Adverse Event Report: UNKNOWN HAKIM VAVLE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number UNK HAKIM

Device Problem Device Operational Issue (2914)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Udi: unknown part number.It is not clear at this point if the device and/or lot information is available.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If the device is returned the complaint will be investigated and a follow up report will be filed.If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Device not available.

Event Description

Patient reported that a fixed pressure valve that was implanted in 1983 is not working properly after a car accident.Pateint reports vision issues and light related seizures.Valve is reported to feel out of place with discomfort.Patient is seeking information about the shunt to see if it can be tapped.No specific device failure has been reported.The device remains implanted.

• Brand Name: UNKNOWN HAKIM VAVLE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7245908
• MDR Text Key: 99181181
• Report Number: 1226348-2018-10109
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HAKIM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2018
• 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