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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number UNK HAKIM
Device Problem Device Difficult to Program or Calibrate (1496)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Udi: unknown part number, attempts to obtain product were unsuccessful, udi unavailable. Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed. 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, about 20 years ago a hakim valve was implanted. The pressure setting is not able to be changed due to a cam drop which was confirmed via imaging. There were no reports of delay or patient harm. The valve will not be returned.
 
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Brand NameHAKIM VALVE
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8103746
MDR Text Key128396160
Report Number1226348-2018-10808
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HAKIM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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