MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE 120CM

Model Number	82-8802PL
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Headache (1880)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The certas valve was not returned for evaluation (remains implanted) 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.
Event or Problem Description
A facility reported that a patient had a certas valve implanted on (b)(6) 2019 with a setting of 4.The patient has a history of headaches and falls prior to the implantation of the valve that goes to back to when the patient was a child.These headaches and falls did not resolve after the certas valve was implanted.In (b)(6) 2020 that patient had an mri for a cerebral cyst and headache.The patient went back to los angeles and had their shunt checked and the setting was at 1.The doctor adjusted it back to 4.It is unknown if the setting had been adjusted between 12/2019 and 10/2020.In (b)(6) 2020, the patient had surgery for the cerebral cyst and headache.On june 25th, the patient had another mri and radiology requested the shunt be checked before and after the mri to determine if the valve setting changed unintentionally or not.It was reported that the valve setting did not change.

• Brand Name: CERTAS PLUS INLINE VALVE 120CM
• Common Device Name: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12147571
• Report Number: 3013886523-2021-00292
• Device Sequence Number: 3782164
• Product Code: JXG
• UDI-Device Identifier: 10886704079026
• UDI-Public: (01)10886704079026(17)240331(10)3671313
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 82-8802PL
• Device Catalogue Number: 828802PL
• Device Lot Number: 3671313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1