MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV W/ SPHNGRD CERTAS PLUS W/ SG

Catalog Number 828805

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

Patient Problems Headache (1880); Cerebral Ventriculomeglia (2133); Vomiting (2144)

Event Date 12/27/2021

Event Type  Injury  

Event Description

A facility reported that on (b)(6) 2021, a certas valve (ref. (b)(4)) was implanted in a (b)(6) year-old male patient due to internal occlusive post-inflammatory hydrocephalus. In the postoperative period there was an increase of the intracranial hypertension and the patient was experiencing headaches in the frontal region and vomiting. On (b)(6) 2021, x-ray computed tomography showed signs of an enlarged fourth ventricle, internal occlusive hydrocephalus, dislocation of the cerebellar tonsils into the foramen magnum. On (b)(6)2021 the patient underwent revision surgery: vp shunt revision, replacement of the programmable valve with ((b)(4)) with pressure level - setting 4. There was an improvement in patient's well-being after revision surgery. Cerebral symptoms regressed.

Manufacturer Narrative

An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: CERTAS INLINE VLV W/ SPHNGRD
• 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: 13081443
• MDR Text Key: 288279283
• Report Number: 3013886523-2021-00566
• 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,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/25/2022

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: 828805
• Device Lot Number: 3843835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown