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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE RIGHT ANGLE W SG CHPV WITH SG

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INTEGRA LIFESCIENCES MANSFIELD PROG VALVE RIGHT ANGLE W SG CHPV WITH SG Back to Search Results
Catalog Number 823182
Device Problem Output Problem (3005)
Patient Problem Injury (2348)
Event Date 12/03/2020
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 that the valve was implanted on (b)(6) 2020 and on (b)(6) 2020, they performed brain mri with the 3t system and at subsequent attempts to calibrate the valve at 130 mmh2o the calibrator never gave the correct calibration signal, and the fluoroscopy control was blocked at 70 mmh2o. There were other attempts to reset the valve, but it was unable to reach the 130 mm h2o opening. There was a surgical delay of 3 hours due to product problem. The valve was explanted on (b)(6) 2020.
 
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Brand NamePROG VALVE RIGHT ANGLE W SG
Type of DeviceCHPV WITH SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA 02048
Manufacturer (Section G)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
mansfield MA 02048
Manufacturer Contact
vivian nelson
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key11074138
MDR Text Key224036225
Report Number3013886523-2020-00282
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823182
Device Lot Number4560702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2020
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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