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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 Obstruction of Flow (2423)
Patient Problems Neurological Deficit/Dysfunction (1982); Hydrocephalus (3272)
Event Date 07/10/2018
Event Type  Injury  
Manufacturer Narrative
The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that the certas valve was occluded after implantation, the patient had neurologic symptoms and the device was revised. The valve was implanted to the patient via l-p shunt; however exact date of implant and initial setting are unknown. The valve was implanted to treat snph. After the surgery, the snph was improved. However, physical symptoms such as a difficulty with walking and the cognitive functional recurred. Ventricular enlargement was confirmed by an image. Pumping of the valve and decreasing of the pressure sitting were tried for a while, but the symptoms did not improve. It was confirmed by contrast media that csf was not flow to the valve side, but it was able to work the spinal side. The revision surgery was performed. No further information was provided by hospital. The product will be returned to your site.
 
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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, CH240 0
SZ CH2400
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
le locle, CH240 0
SZ CH2400
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7740161
MDR Text Key115718476
Report Number1226348-2018-10547
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 foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-8804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
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 Initial

Patient Treatment Data
Date Received: 08/01/2018 Patient Sequence Number: 1
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