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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS INLIN VLV ONLY W/SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS INLIN VLV ONLY W/SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-8804
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 03/10/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Upon completion of the investigation, a follow up report will be filed.
 
Event Description
Procedure cranial surgery. The customer has stated the valves were not functioning correctly and required revising. Valve revised with certas. No ae to patient. No delay in case.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that the images were taken of the valve¿as received¿. The position of the cam when valve was received was at setting 4. The valve was visually inspected: no defects were noted. The valve was hydrated. The valve was tested for programming. The valve passed the test. The valve was flushed, the valve passed the test no occlusion was noted. The valve was leak tested, no leaks were noted. The valve was reflux tested. The valve passed the test. The siphon guard was tested. The valve passed the test. The valve was dried. The siphon guard was removed. The valve was then pressure tested, the valve passed the test. Review of the history device records was not possible as the lot number was unknown. No root cause could be determined, as the problem reported by the customer could not be duplicated. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
 
Event Description
The patient had a shunt in situ which was not functioning correctly she was revised on thursday (b)(6) 2017 and then again on (b)(6) 2017. The surgeon is querying shunt functionality. I have no other information other than the operation symptoms or the patient.
 
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Brand NameCERTAS INLIN VLV ONLY W/SPHNGD
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
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 Key6567322
MDR Text Key75169439
Report Number1226348-2017-10321
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112156
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number82-8804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
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 Initial

Patient Treatment Data
Date Received: 05/15/2017 Patient Sequence Number: 1
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