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

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.

• Brand Name: CHPV INLIN/SG INTEGRAL CON
• Type of Device: CHPV 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 Key: 13020321
• MDR Text Key: 285413228
• Report Number: 3013886523-2021-00559
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• 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 Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 823842
• Device Lot Number: CTGCC6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown