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

Catalog Number 828806

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported that the certas inlin valve (product id 828806) was implanted in a patient due to idiopathic normal pressure hydrocephalus (inph) via l-p shunt in 2019 with unknown setting.The valve was used with a lumbar catheter of a different manufacturer.When the embedded tool kit (etk) was used on the skin directly, the setting could not be changed except for 7 and 8, and if the setting was 8, the patient's symptom became worse.Consequently, the physician scheduled the patient for an appointment in (b)(6) 2021 to change the settings to 6 for better symptoms.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d10, g4, g7,h2, h3, h6, h10.Unique device identifier (udi) : (b)(4).The valve was not returned for evaluation (as per customer, product not available) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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.

• 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
• MDR Report Key: 11096874
• MDR Text Key: 224531501
• Report Number: 3013886523-2020-00288
• 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,u
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1