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

Catalog Number UNK HAKIM

Device Problem Programming Issue (3014)

Patient Problem Headache (1880)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unknown.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

The valve was implanted to the patient on (b)(6) 2017.Initial setting were unk.The patient complained the headache during implant the product and the surgeon tried to changing the pressure setting but it was not able to be changed.The surgeon tried to change the setting by neodymium, pumping and flushing but the issue continued.A revision surgery was performed.The patient¿s information is unknown.No further information available.The product will not be returned to your site.

• Brand Name: UNK HAKIM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7075260
• MDR Text Key: 93479351
• Report Number: 1226348-2017-10908
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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: 11/08/2017
• 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