MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG

Catalog Number 828806

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 12/14/2021

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 certas valve was implanted via l-p shunt on (b)(6) 2021, with setting 7. The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj). On (b)(6) 2021, the setting pressure was changed from 7 to 6. On an unknown day, the physician tried to change the set pressure because the patient's consciousness was not clear, but the set pressure could not be changed. On (b)(6), the physician tried to puncture the valve but couldn¿t, and the physician couldn't get the cerebrospinal fluid. It was suspected shunt dysfunction, therefore, the valve was removed and replaced on (b)(6) 2021.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• Type of Device: CERTAS PLUS W/ 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: 13117030
• MDR Text Key: 282954502
• Report Number: 3013886523-2021-00574
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• 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: 02/09/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 828806
• Device Lot Number: 5355139
• 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: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown