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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV W/ SPHNGRD CERTAS PLUS W/ SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV W/ SPHNGRD CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828805
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Cerebral Ventriculomeglia (2133); Vomiting (2144)
Event Date 12/27/2021
Event Type  Injury  
Event Description
A facility reported that on (b)(6) 2021, a certas valve (ref. (b)(4)) was implanted in a (b)(6) year-old male patient due to internal occlusive post-inflammatory hydrocephalus. In the postoperative period there was an increase of the intracranial hypertension and the patient was experiencing headaches in the frontal region and vomiting. On (b)(6) 2021, x-ray computed tomography showed signs of an enlarged fourth ventricle, internal occlusive hydrocephalus, dislocation of the cerebellar tonsils into the foramen magnum. On (b)(6)2021 the patient underwent revision surgery: vp shunt revision, replacement of the programmable valve with ((b)(4)) with pressure level - setting 4. There was an improvement in patient's well-being after revision surgery. Cerebral symptoms regressed.
 
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
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Brand NameCERTAS INLINE VLV W/ SPHNGRD
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 Key13081443
MDR Text Key288279283
Report Number3013886523-2021-00566
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,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828805
Device Lot Number3843835
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2019
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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