MAUDE Adverse Event Report: Integra LifeSciences Mansfield VENT RES TR RICKHAM LG BA; Internal CSF Drainage

Catalog Number	821623
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is linked to mfg report numbers: (same patient - different events) 3013886523-2025-00216 3013886523-2026-00195 study - biomarin cerliponase alfa observational study "on an unspecified date, the participant underwent implantation of intracerebroventricular device (icv) set (codman rickman icv device; model number 82-1623).The lot number was not reported." "on (b)(6) 2017, the participant was initiated on treatment with brineura (300 milligram, qow, intracerebroventricular use).The lot number for brineura was m006590.The most recent dose was administered on 03-jul-2026." "on (b)(6) 2019, the participant again had an icv set implanted." "on (b)(6) 2026 at 08:22, the participant experienced grade 1 device related infection.Prior to the infusion, on (b)(6) 2026, the participant's csf culture was obtained.On (b)(6) 2026, preliminary results of the culture indicated cuti bacterium (formerly propionibacterium) acnes in thioglycolate broth only.On (b)(6) 2026, final results of the csf culture indicated cuti bacterium (formerly propionibacterium) acnes in thioglycolate broth only.The outcome of the event was reported as recovering/resolving.
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.

• 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 ; +1(609)936-2319
• MDR Report Key: 50374211
• Report Number: 3013886523-2026-00201
• Device Sequence Number: 9884451
• Product Code: JXG
• UDI-Device Identifier: 10381780517788
• UDI-Public: 10381780517788
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 821623
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/11/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Acetaminophen; Cetirizine; Clonazepam; Cyproheptadine; Diastat acudial; Diazepam; Fluoxetine; Levetiracetam; Lidocaine; Miralax; Ondansetron; Risperidone; Tetrabenazine; Topamax; Topamax; Valtoco; Zyrtec
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 67 LB