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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERTAS INLIN VLV SPHN/UNIT CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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MEDOS INTERNATIONAL SARL CERTAS INLIN VLV SPHN/UNIT CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-8806
Device Problem Obstruction of Flow (2423)
Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Hydrocephalus (3272)
Event Date 01/23/2019
Event Type  Injury  
Manufacturer Narrative
Udi -- (b)(4). It has been reported that the device will be returned for evaluation. Upon receipt of the device or additional relevant information, a follow-up report will be submitted.
 
Event Description
It was reported that the certas valve was implanted to the patient via lp-shunt due to normal pressure hydrocephalus. Doi and initial setting were unknown. It was reported that occlusion occurred due to cerebral hemorrhage on day 3 after vp shunt operation and a revision surgery was performed. There is no contamination of blood and debris into the cerebrospinal fluid. The surgeon commented that there was possible cause of intraventricular hemorrhage. No further information was provided by hospital. The product will be returned to your site.
 
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Brand NameCERTAS INLIN VLV SPHN/UNIT CAT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8359991
MDR Text Key136810777
Report Number1226348-2019-10114
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-8806
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2019
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: 02/21/2019 Patient Sequence Number: 1
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