MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERTAS PLUS INLINE WITH SIPHON 828804PL; INTERNAL CSF DRAINAGE

Catalog Number	828804PL
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Headache (1880); Hearing Impairment (1881); Dizziness (2194)
Date of Event	03/05/2026
Type of Reportable Event	Death
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.Additional health effect - clinical code: e1032.E2302.
Event or Problem Description
It was reported a certas valve (id (b)(6)) was over-draining, causing headaches, dizziness, hearing loss, inability to move the neck, vomiting and imbalance.It was also reported that the over-drainage may have caused brain bleeding due to dryness.Doctor turned off the shunt, turned it on again into new settings but issue persisted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h11.The certas valve (id (b)(6)) 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.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
Na.
Additional Manufacturer Narrative
Updated fields: g3, g6, h1, h2, h3, h6, h11.Additional information received from patient's relative: "thanks to you and the drs that did not care for my husband - he died.It is entirely possible that icp caused his heart attack as his cardiologist said his heart was fine and strong two weeks before.".

• Brand Name: CERTAS PLUS INLINE WITH SIPHON 828804PL
• Common Device Name: INTERNAL CSF DRAINAGE
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24714696
• Report Number: 3013886523-2026-00070
• Device Sequence Number: 5726939
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: 10381780521174
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Lay User/Patient
• Device Catalogue Number: 828804PL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 06/08/2026; 08/20/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/29/2026; 07/02/2026; 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other; Death
• Patient Sex: Unknown