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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL

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MEDOS INTERNATIONAL SARL Back to Search Results
Catalog Number UNK CERTAS PLUS
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 11/19/2018
Event Type  Injury  
Manufacturer Narrative
Udi: unknown part number, attempts to obtain product were unsuccessful, udi unavailable. The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the affiliate, a certas plus valve with siphonguard migrated, became inverted, after implant and could not be reprogrammed, then was revised.
 
Manufacturer Narrative
The device was returned for evaluation. The valve was visually inspected; no defects noted. The valve was tested for programming and passed. The valve was flushed; no occlusion was noted. The valve was leak tested; no leaks noted. The catheters were irrigated, no occlusions noted. A small tear/cut was noted in the ventricular catheter. The valve was reflux tested and passed. The siphon guard was tested and passed. The siphon guard was removed. The valve was then pressure tested and passed. A review of manufacturing records could not be performed, as no lot number has been provided. Based on the results of the investigation, the reported issue could not be confirmed. Trends will be monitored for this and similar issues. At present, we consider this complaint to be closed.
 
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Brand NameNI
Type of DeviceNI
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 Key8147752
MDR Text Key129811141
Report Number1226348-2018-10859
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2019
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

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