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Adverse Event Report

CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS   back to search results
Catalog Number 83-3101
Event Date 04/27/2000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

International affiliate reports that when attempting to adjust the valve for overdrainage, the device could not be reprogrammed. The valve was replaced.

 
Manufacturer Narrative

Date sent to fda: 5/16/2000 codman has requested additional info concerning this event. The valve has been returned for eval. Results will be forwarded to the fda upon completion of the eval.

 
Manufacturer Narrative

See h10.

 
Manufacturer Narrative

Examination of the returned device revealed the presence of bio-substance residues within the valve mechansim. These substances prevented the valve from programming correctly and the pressure test from being performed. A review of production batch records confirmed that the valve met specifications when released to stock. The complaint cannot be confirmed as it is appears that the bio-substances caused the programming difficulties encountered by the customer. At this time, the complaint is considered to be closed.

 
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Brand NameHAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Baseline Brand NameHAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER
Baseline Generic NameSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Baseline Catalogue Number83-3101
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CODMAN & SHURTLEFF, INC.
medos s.a.
rue giradet 29
le locle
SWITZERLAND CH-2400
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
medos s.a.
rue giradet 29
le locle
SWITZERLAND CH-2400
Manufacturer Contact
matthew king
325 paramount dr
raynham , MA 02767
(508) 828 -3212
Device Event Key268794
MDR Report Key277701
Event Key260406
Report Number1226348-2000-00003
Device Sequence Number1
Product CodeJXG
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/15/2000,05/16/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2000
Is This An Adverse Event Report? No
Device Operator Health Professional
Device EXPIRATION Date10/31/2003
Device Catalogue Number83-3101
Device LOT NumberPH3939
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/12/2000
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/12/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/1998
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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