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

Model Number	82-8800PL
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Cerebral Ventriculomegaly (2133); Lethargy (2560)
Date of Event	08/05/2022
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 facility reported a certas valve (id 828800pl) was implanted on (b)(6), 2019.On (b)(6), 2022 the patient attempted to have shunt reprogrammed from a setting 5 to 6.They attempted to reprogram to 6 and both the manual and electronic program confirmed change.The patient was sent down to x-ray to confirm but x ray continued to show valve was at a 5.They set shunt at 7 as that was closest to 6 but on august 05, 2022, patient presented with shunt failure symptoms, therefore, the valve was explanted and replaced with a new valve.The patient was having signs of ventricular enlargement and severe lethargy when underdraining.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The certas valve (id 828800pl) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 7.The valve was visually inspected; no defects were noted.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux and pressure.No root cause could be determined as the technician could not confirm any problems with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve, at the time of investigation no programing issues were noted.

• Brand Name: CERTAS PLUS INLINE VALVE ONLY
• Common Device Name: CERTAS PLUS
• 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: 15284170
• Report Number: 3013886523-2022-00394
• Device Sequence Number: 7111094
• Product Code: JXG
• UDI-Device Identifier: 10886704079002
• UDI-Public: (01)10886704079002(17)240731(10)4009848
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: 07/31/2024
• Device Model Number: 82-8800PL
• Device Catalogue Number: 828800PL
• Device Lot Number: 4009848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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