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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERTAS INLIN VLV ONLY W/SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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MEDOS INTERNATIONAL SARL CERTAS INLIN VLV ONLY W/SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-8804
Device Problem Restricted Flow rate (1248)
Patient Problem Hydrocephalus (3272)
Event Date 08/28/2018
Event Type  Injury  
Manufacturer Narrative
Udi: (b)(4). 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 experienced worsening hydrocephalus and the device was revised. The valve was implanted to the patient via lp; however, the initial setting is unk. After implantation, the patient moved to another hospital, where it was confirmed that snph was getting worse, so the patient came back. 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)
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 Key7889353
MDR Text Key120728327
Report Number1226348-2018-10663
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
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 Manufacturer09/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
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: 09/19/2018 Patient Sequence Number: 1
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