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	Bacterial Infection (1735)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch number: (b)(4)."the participant's past medical history included: sars-cov-2 antibody test positive, and drug delivery device placement.The participant's concurrent conditions included: dysarthria, intellectual disability, gait disturbance, muscle spasticity, knee deformity, neuronal ceroid lipofuscinosis, blood cholesterol decreased, ataxia,carotid pulse, and hypertonia.No allergies were reported.Concomitant medications included: levetiracetam, gemfibrozil, nutrients nos, and trihexyphenidyl hydrochloride.Paracetamol, cetirizine hydrochloride, lidocaine hydrochloride, ondansetron hydrochloride, rifampicin, vancomycin hydrochloride, and ibuprofen were used as premedication for the participant's brineura infusions." "on (b)(6) 2017, the participant was initiated on treatment with brineura (300 milligram, qow, intracerebroventricular).The lot number for brineura was m006590.The most recent dose was administered on (b)(6) 2026." "on (b)(6) 2018, the participant underwent implantation of an intracerebral ventriculostomy (icv) set (codman & shurtleff; rickham model number 82-1623).The lot, serial, catalogue and udi numbers were not reported." "on (b)(6) 2026, the participant's cerebrospinal fluid (csf) sample was collected, and the analysis results revealed a few white bloodcells but no organisms were seen.At 08:47, the participant developed grade 1 device related infection (device relatedinfection).On 07-jul-2026, the csf was positive and preliminary results revealed cutibacterium (formerly propionibacterium)acnes in thioglycollate broth only - susceptibility to follow preliminary.On (b)(6) 2026, final results revealed cutibacterium (formerly propionibacterium) acnes in thioglycollate broth only.No treatment for the event was administered.No action was taken with brineura due to the event.It was reported that the device was not available for return.".
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: 50175251
• Report Number: 3013886523-2026-00193
• Device Sequence Number: 8270452
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Study
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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
• Device Lot Number: M006590
• 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: 07/17/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 10/01/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Sex: Male