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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG CHPV WITH SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG CHPV WITH SG Back to Search Results
Model Number 82-3832
Device Problem Mechanical Problem (1384)
Patient Problem Failure of Implant (1924)
Event Date 02/25/2022
Event Type  Injury  
Event Description
A physician reported a hakim valve was implanted via v-p shunt on unknown date with unknown setting. The patient visited the hospital on (b)(6) 2022 and an mri examination was performed. The set pressure before mri imaging was 200 mmh2o, but when the set pressure was confirmed under fluoroscopy, the pressure changed to 30 mmh2o. Therefore, the pressure did not change even after changing the pressure and confirming it by fluoroscopy again. The pressure could not be changed even with neodymium. The valve was removed and replaced on (b)(6), 2022.
 
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 NamePROG VALVE INLINE W SG
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 Key13792169
MDR Text Key289777752
Report Number3013886523-2022-00096
Device Sequence Number1
Product Code JXG
UDI-Device Identifier10886704041825
UDI-Public(01)10886704041825(17)230930(10)3214681
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number82-3832
Device Catalogue Number823832
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2018
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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