MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD CERTAS PLUS W/ SG

Catalog Number 828804

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

Patient Problem Failure of Implant (1924)

Event Date 12/06/2021

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

1 of 2 reports. Other mfg report number: 3013886523-2021-00565. A physician reported a certas valve was implanted via l-p shunt on (b)(6) 2021 with unknown setting. The valve was used with 823074 and the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj). Shunt dysfunction occurred (unknown failure) and the valve and bactiseal peritoneal catheter were removed and replaced on (b)(6) 2021. A large amount of blood was found in the explanted valve. It is unknown if the patient experienced any signs and symptoms due to valve failure.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• 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: 13077345
• MDR Text Key: 282711263
• Report Number: 3013886523-2021-00564
• 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: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 828804
• 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
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown