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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPSV

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPSV Back to Search Results
Catalog Number 82-3832
Device Problem Restricted Flow rate (1248)
Patient Problem No Information (3190)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
During the implantation procedure. Doi and initial setting were unk. It was reported that when trying to flush during the surgery, the physiological saline did not flow firmly and eventually it could not confirm the flow of csf. No further information was provided by hospital. The product will not be returned to your site. The product will be returned to your site.
 
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Brand NamePROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPSV
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7161304
MDR Text Key281079675
Report Number1226348-2018-10010
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 company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-3832
Device Lot Number138441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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