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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
Catalog Number 823162
Device Problem Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Date 11/09/2021
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 on unknown date with unknown setting. The postoperative status was stable, however, the patient had a cerebral hemorrhage in (b)(6) 2021. In late august, the set pressure of the valve could not be changed. In september and october, the set pressure could not be changed even with neodymium. The valve was removed and replaced on (b)(6) 2021.
 
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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 Key12869349
MDR Text Key281210220
Report Number3013886523-2021-00521
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K041296
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 02/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Catalogue Number823162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2012
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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