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	Pressure Problem (3012)
Health Effect - Clinical Codes	Vomiting (2144); Irritability (2421)
Date of Event	03/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a certas valve was implanted with setting 5 on (b)(6) 2020 to treat hydrocephalus.Due to some blood in the ventricles, the setting was changed to 7 on the same day.On (b)(6) 2020, the setting was changed to 5 with digital and magnetic confirmation.In (b)(6) 2022, the patient's parents called informing the patient had irritability which progressed into vomiting and it was found the valve was set at setting 8 (supposed to be in 5).It is unknown if the patient had magnetic exposure, mris, etc.The valve was adjusted to setting 5, confirmed on the machine and x-ray.Patient improved.
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
A certas valve (id 828810pl) was not returned for evaluation (remains implanted) 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.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: 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: 13938519
• Report Number: 3013886523-2022-00114
• Device Sequence Number: 4612082
• Product Code: JXG
• UDI-Device Identifier: 10886704081890
• UDI-Public: 10886704081890
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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 Model Number: 82-8810PL
• Device Catalogue Number: 828810PL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/19/2022
• 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: 20 MO
• Patient Sex: Male