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

Catalog Number	821621
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
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
Medwatch: (b)(4)."on an unreported date, the patient underwent implantation of an intracerebral ventriculostomy (icv) set (unspecified codman rickham, model and lot number not reported).On an unreported date, approximately 9 months prior to the report, the patient initiated treatment with brineura (dose and frequency not reported, intracerebroventricular) for the indication of neuronal ceroid lipofuscinosis.The most recent dose was administered on an unreported date." "on an unreported date, there was a failure of the rickham reservoir.There was collapse of the dome, and the needle needed to be inserted directly in the central hole of the titanium plate of the reservoir, which caused technical challenges and required sedation with intravenous ketamine and midazolam hydrochloride.No laboratory or diagnostic test results were reported.There were plans to change the reservoir due to the event." "the action taken with brineura due to the event was not reported.The outcome of the event was not reported." "the reporter did not provide an assessment of the event of the device failure in relation to treatment with brineura.The reporter assessed the event as related to the rickham reservoir device.In the reporter's opinion, other possible etiological factors included repetitive punctures of the dome, or low csf pressure." "the patient's concurrent conditions included neuronal ceroid lipofuscinosis, vomiting, and dysphagia." case comment: "event of device failure with collapse of the dome reported as likely due to repetitive punctures or low csf pressure.The causality of event is assessed as not related to brineura.".
Additional Manufacturer Narrative
The rickham reservoir 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, however, a possible root cause for the issue reported by the customer, could not be clearly determined but could be linked to, too many needle holes in the reservoir.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.Additional information received: implantation date? on (b)(6) 2023, please indicate how the rickham reservoir failure was noticed: on (b)(6) 2024, the neurosurgeon at the clinic had difficulty plugging the needle into the rickham reservoir.Did the patient experience any signs and symptoms due to rickham reservoir failure? if yes, please explain.As noted in the report, the patient experienced pain during the reservoir puncture procedure.Timeframe between the implantation and the onset of signs and symptoms? implantation (b)(6) 2023 and failure on (b)(6) 2024: 8 months.Was the rickham reservoir explanted? no, the rickham reservoir had not been removed.The patient was given intravenous ketamine for sedation and pain relief.How is the patient now? as per the reporter, the patient had recovered.No further information was available.
Additional Manufacturer Narrative
Product id provided - 821621: dhr - lot: 7034052, conformed to the specifications when released to stock.Additional information: reservoir implanted in 2023."we decided to stop the treatment.The number of injections varied depending on the sessions, from one to 4 attempts, most often only one." decision to stop treatment due to lack of efficacy and at the request of the family.Not planned an explantation, given the risk of general anesthesia versus the almost zero risk of infection, on the advice of neurosurgeons.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information received: - "decision to stop treatment due to lack of efficacy and at the request of the family." - "we have not planned an explantation, given the risk of general anesthesia versus the almost zero risk of infection, on the advice of neurosurgeon".

• Brand Name: VENT RES TR RICKHAM ST BA
• Common Device Name: RESERVOIRS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20524317
• Report Number: 3013886523-2024-00329
• Device Sequence Number: 18403147
• Product Code: JXG
• UDI-Device Identifier: 10381780517771
• UDI-Public: (01)10381780517771(17)280131(10)7034052
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/21/2025

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 Catalogue Number: 821621
• Device Lot Number: 7034052
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 11/01/2024; 02/19/2025; 03/04/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/22/2024; 03/07/2025; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2023
• 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: Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female