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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM VALVE, RIGHT ANGLE RES. UNITIZED SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. HAKIM VALVE, RIGHT ANGLE RES. UNITIZED SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3146
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Headache (1880); Failure of Implant (1924); Neurological Deficit/Dysfunction (1982)
Event Date 01/11/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed. A review of manufacturing records found no discrepancies when the device was released. The cause(s) of the difficulty reported by the customer could not be determined. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
 
Event Description
As reported by the ous affiliate, after 10 years, a hakim valve was suspected of overdraining and was revised. The original setting was 60mmh20. The patient felt lightheaded and had headache. The setting of the valve was changed, however the pressure did not change and the over drainage was confirmed and a revision surgery was performed. The setting of the removed valve was 200mmh20. The valve was implanted due to idiopathic normal pressure hydrocephalus. The patient has recovered.
 
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Brand NameHAKIM VALVE, RIGHT ANGLE RES. UNITIZED SG
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8319738
MDR Text Key135501933
Report Number1226348-2019-10086
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992173
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,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2012
Device Catalogue Number82-3146
Device Lot NumberCHDBV2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2007
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: 02/08/2019 Patient Sequence Number: 1
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