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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CHPV INLIN/SG INTEGRAL CON CHPV WITH SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CHPV INLIN/SG INTEGRAL CON CHPV WITH SG Back to Search Results
Catalog Number 823842
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cerebral Ventriculomeglia (2133)
Event Date 11/30/2021
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 hakim valve was implanted via v-p shunt in 2019 with unknown setting. During a follow-up visit it was noticed that the size of the ventricles had increased. The patient had no symptoms and when the physician tried to pump the valve, it did not work. Therefore, the valve was removed and replaced on (b)(6) 2021.
 
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 hakim valve was implanted via v-p shunt in 2019 with unknown setting. During a follow-up visit it was noticed that the size of the ventricles had increased. The patient had no symptoms and when the physician tried to pump the valve, it did not work. Therefore, the valve was removed and replaced on (b)(6) 2021.
 
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Brand NameCHPV INLIN/SG INTEGRAL CON
Type of DeviceCHPV WITH 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 Key13020321
MDR Text Key285413228
Report Number3013886523-2021-00559
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K053107
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 02/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Catalogue Number823842
Device Lot NumberCTGCC6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2015
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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