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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 Problem Device Difficult to Program or Calibrate (1496)
Patient Problem Failure of Implant (1924)
Event Date 10/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the ous affiliate, approximately 15 years after implant, a hakim valve can not be reprogrammed. The patient has undergone a lot of mri's and was revised.
 
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Brand NameHAKIM PROGRAMMABLE VALVE
Type of DeviceCNS SHUNT
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8106157
MDR Text Key128419046
Report Number1226348-2018-10813
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2008
Device Catalogue Number82-3111
Device Lot Number1092367
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/27/2018 Patient Sequence Number: 1
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