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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAKIM PROGRAMMABLE VALVE; CNS SHUNT
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HAKIM PROGRAMMABLE VALVE; CNS SHUNT Back to Search Results
Catalog Number 82-3111
Device Problems Component Missing (2306); Unintended Movement (3026)
Patient Problem No Information (3190)
Event Date 06/17/2015
Event Type  Injury  
Event Description
I spoke with a woman today from the surgery department.She has a shunt that she would like to send to codman for examination.She needs an explant kit sent to her as well as the complaint form so she can fill out the information and return the product.On (b)(6) 2015, valve failure.Radiographic marker was absent.It appears that the valve wheel was displaced or it was auto resetting the wheel causing random movement.The patient was taken to the operating room and had the non functioning valve replaced with a new one.
 
Manufacturer Narrative
Upon completion of the investigation a follow up report will be filed.
 
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Brand Name
HAKIM PROGRAMMABLE VALVE
Type of Device
CNS SHUNT
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key4922925
MDR Text Key15590831
Report Number1226348-2015-10415
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
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 Received07/17/2015
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2013
Device Catalogue Number82-3111
Device Lot NumberCJNBTF
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received06/30/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age6 YR
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