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U.S. Department of Health and Human Services

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

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS PLUS PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number UNK CERTAS PLUS
Device Problem Obstruction of Flow (2423)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Date 06/11/2018
Event Type  Injury  
Manufacturer Narrative
Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed. The cause(s) of the difficulty reported by the customer could not be determined. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
 
Event Description
As reported by the patient, a certas plus valve became blocked approximately 1 year after implant. The patient was experiencing neurologic deficits, described as severe headaches, dizziness, and vision issues. The valve was revised; however, the shunt catheter system remains implanted. The complaint device was replaced with another valve. The patient reports no further symptoms since the complaint valve was replaced.
 
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Brand NameCERTAS PLUS PROGRAMMABLE VALVE
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
le locle, CH240 0
SZ CH2400
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
le locle, CH240 0
SZ CH2400
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key7736845
MDR Text Key115646746
Report Number1226348-2018-10534
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK CERTAS PLUS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/31/2018 Patient Sequence Number: 1
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