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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNKNOWN CERTAS PLUS VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNKNOWN CERTAS PLUS VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number UNK CERTAS
Device Problems Restricted Flow rate (1248); Material Separation (1562)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Date 04/09/2018
Event Type  Injury  
Manufacturer Narrative
It has been reported that the device will be returned for evaluation. Upon completion of the investigation, a follow-up will be submitted.
 
Event Description
As reported by the (b)(4) affiliate, an unknown certas valve was revised. The patient presented with altered consciousness and valve blockage was suspected. During the revision, it was noted that the siphon guard was broken/separated from the valve. The patient symptoms resolved with the revision of the valve.
 
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Brand NameUNKNOWN CERTAS PLUS VALVE
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29 case postale
le locle CH240 0
SZ CH2400
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29 case postale
le locle CH240 0
SZ CH2400
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7466027
MDR Text Key106697780
Report Number1226348-2018-10306
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK CERTAS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/26/2018 Patient Sequence Number: 1
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