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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828806
Device Problem Infusion or Flow Problem (2964)
Patient Problems Cerebral Ventriculomeglia (2133); Confusion/ Disorientation (2553)
Event Date 09/03/2020
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported that in (b)(6) 2020 the certas valve was implanted on a (b)(6) male patient via an l-p shunt with a setting of 4.However, the patient presented disorientation and cerebral ventricular enlargement was confirmed at the diagnostic imaging.So, the setting was lowered in steps from 4 to 3 to 2.On (b)(6) 2020, the patient¿s symptoms did not improve, and the setting was lowered to 1.On (b)(6) 2020, a contrast study confirmed that there was no flow from the valve.Therefore, the physician planned the replacement on (b)(6).No further information was provided by the hospital.
 
Manufacturer Narrative
Udi : (b)(4).The certas valve was returned for evaluation: failure analysis - the valve was visually inspected; needle holes in the needle chamber were noted.The valve passed the tests for programming, occlusion, leaks, reflux, siphon guard and pressure.No root cause could be determined for the problem reported by the customer as the technician could not confirm an occlusion with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up this could interfere with the valve mechanism, but at the time of investigation no occlusions were noted.
 
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Brand Name
CERTAS INLIN VLV SPHN/UNIT CAT
Type of Device
CERTAS PLUS W/ SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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MDR Report Key10576836
MDR Text Key208306182
Report Number3013886523-2020-00119
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K143111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number828806
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Initial Date Manufacturer Received 09/03/2020
Initial Date FDA Received09/23/2020
Supplement Dates Manufacturer Received10/15/2020
Supplement Dates FDA Received11/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age78 MO
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