MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Catalog Number	828804PL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Headache (1880); Hearing Impairment (1881); Vomiting (2144)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a certas plus valve setting changed (from 4 to 0) following a research 3t magnetic resonance imaging (mri).The patient had the valve implanted on (b)(6), 2023 with setting 4, confirmed at 4 with electronic programmer at last clinic appointment.Per normal pressure hydrocephalus (nph) study protocol a ¿research magnetic resonance imaging (mri)¿ was performed on (b)(6), 2023.Patient then presented on (b)(6), 2023 to emergency room with headache, vomiting, meningismus and hearing loss in one ear.Patient was admitted, and then reprogrammed to correct setting.Following admittance to the hospital, and the reprogramming of the valve the patient was asymptomatic and the issues were resolved within 24 hours.Patient was discharged the next day without issue.
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
N/a.
Additional Manufacturer Narrative
Additional information received: - based on the answer previously provided, it was stated that ¿valve changed setting from 4 to 0 on 12/6 mri brain¿.Settings are normally 1-8, there is no zero.Kindly confirm and provide the correct setting.Answer = 4 to 1.- what was used to confirm the setting? manual toolkit, electronic toolkit, or x-ray? answer: confirmed with electronic toolkit.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The certas valve (828804pl) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a possible root cause for the issue reported by the customer could be due to valve no longer mri resistant, can unintentionally change to any setting more than 1 setting away from the desired setting.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 PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ SG
• 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: 18449907
• Report Number: 3013886523-2024-00002
• Device Sequence Number: 7092257
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: 10381780521174
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2024

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 Catalogue Number: 828804PL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/12/2024; 01/24/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/19/2024; 02/09/2024
• 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 Age: 76 YR
• Patient Sex: Male