MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD VENT RES TR RICKHAM ST BA; RESERVOIRS

Catalog Number	821621
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An investigator reported this case from the biomarin study; cerliponase alfa observational study.7 years-old female subject: past medical history was not reported.On an unspecified date, the subject underwent implantation of intracerebral ventriculostomy (icv) set (manufacturer, model number, and lot number not reported).On (b)(6) 2018, the subject initiated treatment with brineura (150 milligram, qow, intracerebroventricular).The lot number for brineura was not reported.The most recent dose was administered on (b)(6) 2020.On (b)(6) 2022 at 10:26, the subject experienced grade 1 device malfunction (device malfunction) after repeated tapping in addition to injections with brineura that caused some reactive inflammation and obliterated the device system.No laboratory or diagnostic tests were reported.No 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) 2022.The investigator assessed the event of device malfunction as not related to treatment with brineura and related to the icv device.No other etiological factors were reported.Additional information received on 18-oct-2022: the subject's brineura dose was updated by the reporter from 150 milligram to 10 milligram.The most recent dose administered was updated from (b)(6) 2020.The time the event ended was reported as 16:15 on 0(b)(6) 2022.Additional information received on 28-nov-2022: on (b)(6) 2018, the subject underwent implantation of intracerebral ventriculostomy (icv) set (codman holter; model reported as selker standard) lot number 10749 and serial number reported as (b)(6).On (b)(6) 2022, the icv device was removed from the subject.Additional information received on 15-feb-2024: the participant's brineura dose was updated from 10 milligram to 250 milligram.The brineura lot number was unknown.The most recent dose of brineura was administered on (b)(6) 2022 at 11:50.Biomarin pharmaceutical has assessed the event as medically significant.Additional information received on 01-apr-2025: the icv device model number was 821621.The icv device lot number, previously reported as 10749, was updated by the investigator to 107049.The operator of the device was the investigator; the location of the event was at the clinic and 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Complaint sample was not returned for evaluation as the product was discarded; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (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.

• Brand Name: VENT RES TR RICKHAM ST BA
• Common Device Name: RESERVOIRS
• 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: 21930636
• Report Number: 3013886523-2025-00088
• Device Sequence Number: 21090350
• Product Code: JXG
• UDI-Device Identifier: 10886704040484
• UDI-Public: (01)10886704040484(17)211031(10)107049
• Combination Product (Y/N): N
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 821621
• Device Lot Number: 107049
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2016
• 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: CLEMASTINE FUMARATE; GRANISETRON; HYDROXYZINEHYDROCHLORIDE; LEVETIRACETAM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female