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Adverse Event Report

CODMAN & SHURTLEFF, INC. MEDOS S.A. HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS   back to search results
Catalog Number 82-3100
Event Date 01/06/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

Visual examination of the returned valve found its cam to be loose within the valve casing. As results, the valve coulds not be functionally tested for programming or pressure. Review of the device history record confirmed the valve meet specification requirements when released to stock. It apears that the pt may have fallen or suffered an impact to the implanted valve that caused the cam to loosen, however, that can not be positively determined. At this time, the complaint is considered to be closed.

 
Manufacturer Narrative

See h10.

 
Manufacturer Narrative

Codman has requested return of the device for eval. Results will be forwarded to the fda upon receipt of the device and completion of the eval.

 
Event Description

The valve was implanted in 1995 (exact date unknown). In the end of 2002 and in 2003 the valve pressure could not be changed and the device was explanted. Examination upon removal of the valve revealed an internal component had become dislodged.

 
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Brand NameHAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS
Baseline Brand NameHAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
Baseline Generic NameSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Baseline Catalogue Number82-3100
Baseline Device FamilyHAKIM PROGRAMMABLE VALVES
Baseline Device 510(K) NumberK974739
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed07/01/1998
Manufacturer (Section F)
CODMAN & SHURTLEFF, INC. MEDOS S.A.
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SWITZERLAND CH-2400
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. MEDOS S.A.
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SWITZERLAND CH-2400
Manufacturer Contact
matthew king
325 paramount drive
raynham , MA 02767
(508) 828 -3106
Device Event Key431100
MDR Report Key442122
Event Key418481
Report Number1226348-2003-00033
Device Sequence Number1
Product CodeJXG
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 01/16/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number82-3100
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2003
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/16/2003
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/1995
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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