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

Catalog Number 828806

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

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 shunt valve programming issue post implantation.A certas valve was implanted in a patient via a lumbar peritoneal shunt on an unknown date in 2017 with an unknown initial setting.The patient appeared disoriented on january 27, 2021.The provider attempted to adjust the shunt valve setting but was reportedly not able to with the codman certas tool kit.The patient was taken for a fluoroscopy study and the provider was unable to change the setting under fluoroscopy.The ¿etk and neodymium¿ were used to change the setting, but were also unable to change the setting.After confirming the patient's condition, the provider found that the patient's ventricles were reduced and improved by pumping the shunt valve under fluoroscopy and adjustment of settings with magnets.At first, it was scheduled to replace, but it was cancelled because the patient¿s condition has improved with the valve pumping and adjustment of the settings.

Manufacturer Narrative

The certas 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: 11327270
• MDR Text Key: 232803352
• Report Number: 3013886523-2021-00077
• 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
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 828806
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1