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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of consciousness (2418)
Event Date 12/14/2021
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported a certas valve was implanted via l-p shunt on (b)(6) 2021, with setting 7. The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj). On (b)(6) 2021, the setting pressure was changed from 7 to 6. On an unknown day, the physician tried to change the set pressure because the patient's consciousness was not clear, but the set pressure could not be changed. On (b)(6), the physician tried to puncture the valve but couldn¿t, and the physician couldn't get the cerebrospinal fluid. It was suspected shunt dysfunction, therefore, the valve was removed and replaced on (b)(6) 2021.
 
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Brand NameCERTAS INLIN VLV SPHN/UNIT CAT
Type of DeviceCERTAS PLUS W/ SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key13117030
MDR Text Key282954502
Report Number3013886523-2021-00574
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,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828806
Device Lot Number5355139
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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