MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL VLV ONLY; CERTAS PLUS SMALL & RA

Model Number	82-8810PL
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A physician reported a certas valve was placed on (b)(6) 2019, and had to be readjusted multiple times due to value setting movement.The shunt setting changed after the patient was sent to mri and changed on its own 2 additional times after the patient has fell.The shunt was set at 2 and when the patient went back to the clinic on both occasions the shunt setting changed to 1 and had to be reset back to 2.They doubled checked the shunt with 2 programmers to make sure everything was accurate.The patient presented symptoms due to valve setting changes (¿mom stated his eyes were glossed over and not being himself¿).
Additional Manufacturer Narrative
The certas valve was returned for evaluation: dhr - lot 3446884 conformed to the specifications when released to stock failure analysis - the position of the cam when valve was received was at setting 2.The valve was visually inspected; no defects was noted.The valve passed the tests for programming, occlusion, leaks, reflux.The valve was pressure tested, the valve failed the test at setting 8.The rotation construct stayed in up position after being programmed in setting 8.The rotation construct being stuck in up position, the programming was not locked and the rotation construct moved freely.The valve was dismantled and visually inspected under microscope at appropriate magnification: biological debris in the spring was noted.The root cause for the issue reported by the customer was due to biological debris and protein build up interfering with the valve mechanism.The biological debris stuck in the spring kept the rotation construct in up position after a programming.The rotation construct being stuck in up position, the programming was not locked and the rotation construct moved freely.
Event or Problem Description
N/a.

• Brand Name: CRTS SM IL VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA
• 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: 13117043
• Report Number: 3013886523-2021-00569
• Device Sequence Number: 4653882
• Product Code: JXG
• UDI-Device Identifier: 10886704081890
• UDI-Public: (01)10886704081890(17)231231(10)3446884
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2029
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 82-8810PL
• Device Catalogue Number: 828810PL
• Device Lot Number: 3446884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown