MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE CLYNDRICAL; CHPV

Catalog Number 823115

Device Problem Break (1069)

Patient Problem Hydrocephalus (3272)

Event Date 01/16/2024

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 sales representative reported: "on (b)(6) 2022, the patient had hydrocephalus symptoms and a destroyed mechanism was seen on x-ray.They talked about it as part of a further training course." the valve was implanted on (b)(6) 2013; explanted and replaced on (b)(6) 2024.The boy has had a total of 7 mris in his life, the last one was on (b)(6) 2024.The valve defect also occurred during this time.

• Brand Name: PROG VALVE CLYNDRICAL
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18841821
• MDR Text Key: 336957753
• Report Number: 3013886523-2024-00067
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K122118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823115
• Date Manufacturer Received: 02/20/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1