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Adverse Event Report

CODMAN & SHURTLEFF, INC. MEDOS S.A. HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS   back to search results
Catalog Number 82-3100
Event Date 07/17/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

See h10.

 
Manufacturer Narrative

Codman has requested return of the valve for evaluation. A follow up report will be filed upon receipt of the device and completion of the evaluation.

 
Event Description

International affiliate reports fluid did not flow though the implanted valve due to some form of blockage. The device was explanted.

 
Search Alerts/Recalls

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Brand NameHAKIM PROGRAMMABLE VALVE
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 G)
CODMAN & SHURTLEFF, INC. MEDOS S.A.
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SWITZERLAND CH-2400
Manufacturer Contact
matthew king
325 paramount drive
raynham , MA 02768
(508) 828 -3106
Device Event Key529730
MDR Report Key540421
Event Key513146
Report Number1226348-2004-00260
Device Sequence Number1
Product CodeJXG
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/26/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2004
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? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/26/2004
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on December 31, 2008

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