MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS RA SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Catalog Number 828824

Device Problem Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Nausea (1970)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The certas valve was not returned for evaluation (per customer, valve not available) therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up this could interfere with the valve mechanism.

Event Description

A physician reported over drainage from a shunt valve.The patient had a certas valve implanted for idiopathic normal pressure hydrocephalus via a ventricular peritoneal shunt on (b)(6) 2020 with an initial setting of 7.The valve was used with bactiseal (ns0340).After placing the valve, the hydrocephalus symptoms improved for 3 days.However, on (b)(6) 2020 the patient complained of headache and nausea and it was found that over drainage occurred.The patient reportedly developed a ¿chronic subdural hematoma suddenly.¿ the setting was changed to 8 but the symptoms did not improve.On (b)(6) 2020, a new certas valve was added in series behind the existing valve.The valve was changed to a setting of 8.The patient continues to follow-up.

• Brand Name: CRTS RA SG VLV ONLY
• Type of Device: CERTAS PLUS SMALL & RA 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 ; 325 paramount drive; raynham, MA 02767 ; 6099362319
• MDR Report Key: 10892004
• MDR Text Key: 217951656
• Report Number: 3013886523-2020-00220
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828824
• Device Lot Number: 4802842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2020
• Date Device Manufactured: 07/08/2020
• 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
• Patient Age: 78 YR
• Patient Weight: 68