MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD VENT RES TR RICKHAM LG BA; INTERNAL CSF DRAINAGE

Catalog Number	821623
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2025
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
Cerliponase alfa observational study - this case is a report referring to a 7-year-old male participant."on (b)(6) 2021, the participant underwent implantation of intracerebral ventriculostomy (icv) set (codman generic; model not reported) lot number 5021995." "on (b)(6) 2021, the participant was initiated on treatment with brineura (300 milligram, qow, intracerebroventricular use).The lot number for brineura was unknown." on (b)(6) 2025, it took five attempts to access the participant's port for the infusion which began at 09:25.At 13:45, after the infusion, the site was damp and appeared to be leaking.The leak did not stop so it was determined that the device needed to be replaced.At 14:20, it was determined that the participant experienced a grade 3 intraventricular reservoir leak (device leakage) and was hospitalized on an unspecified date.On (b)(6) 2025, the participant's icv device was removed.No laboratory or diagnostic tests were reported.No additional treatment for the event was reported.No action was taken with brineura due to the event." "the outcome of the event was reported as recovered/resolved on (b)(6) 2025 at 18:03." "the investigator assessed the event of (device leakage) as related in relation to the icv device.Other possible etiological factors included device failure was well past it's expected life and that this is an expected situation.".
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h11.The rickham reservoir (id 821623) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history records (dhr) was reviewed, and no anomalies were found.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.A corrective and preventative action (capa) was initiated: description of change: remediation of holter reservoir ifu.Changes done: update of section with catalog number; update injection section (precaution of 25 punctions max in the dome, at multiples locations, to avoid any risk of tearing); correct ec rep address; update section about trademarks; add website.
Event or Problem Description
N/a.

• Brand Name: VENT RES TR RICKHAM LG BA
• 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: 23988175
• Report Number: 3013886523-2025-00345
• Device Sequence Number: 4554491
• Product Code: JXG
• UDI-Device Identifier: 10381780517788
• UDI-Public: (01)10381780517788(17)250930(10)5021995
• Combination Product (Y/N): N
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 09/30/2025
• Device Catalogue Number: 821623
• Device Lot Number: 5021995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN (PARACETAMOL); CLOBAZAM (CLOBAZAM); CLONIDINE (CLONIDINE HYDROCHLORIDE); CLONIDINE (CLONIDINE HYDROCHLORIDE); DEPAKOTE (VALPROATE SEMISODIUM); DIAZEPAM (DIAZEPAM); DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE); EPINEPHRINE (EPINEPHRINE); GUANFACINE (GUANFACINE HYDROCHLORIDE); IBUPROFEN (IBUPROFEN); LEVETIRACETAM (LEVETIRACETAM); METHYLPREDNISOLONE SODIUM SUCCINATE; MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE); ZOFRAN (ONDANSETRON HYDROCHLORIDE)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 16 KG