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

Model Number	82-1621
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	12/18/2019
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
Study; patient receives intraventricular enzyme therapy every 14 days via rickham reservoir at cln2.After the intraventricular therapy on (b)(6) 2019 there was a clear liquid leak on (b)(6) 2019.Rickham was replaced on (b)(6) 2019.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information received: on (b)(6)2019 : patient initiated treatment with brineura for the indication of neuronal ceroid lipofuscinosis.On (b)(6)2021 : patient developed a device issue and spontaneous cerebrospinal fluid leak syndrome which required hospitalization.On an unreported date, the patient's icv device was removed and a new one was inserted.No laboratory or diagnostics tests were reported.The outcome of the event was reported as resolved on an unreported date.The event is not linked to brineura therapy.
Additional Manufacturer Narrative
Complaint sample was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined, however, the possible root cause for the ¿the faulty reservoir ¿reported by the customer could be due to a sharp or pointed object coming into contact with the device, as noted in the ifu silicone has a low cut/tear resistance.As the device has not been returned for investigation this could not be confirmed.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 Manufacturer Narrative
Additional information received: on (b)(6), 2019, the rickham reservoir was removed and a new one was installed.The reporter assessed the event of spontaneous cerebrospinal fluid leak syndrome as unknown in relation to treatment with brineura.The reporter did not provide an assessment of the event of spontaneous cerebrospinal fluid leak syndrome in relation to the icv device.No other etiological factors were reported.No further information was available.Case comment: the patient experienced spontaneous cerebrospinal fluid leak syndrome due to device issue, which is known complication of icv devices.The causality of event is assessed as not related to brineura.
Event or Problem Description
N/a.

• 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 ; 6099362319
• MDR Report Key: 13861651
• Report Number: 3013886523-2022-00100
• Device Sequence Number: 4691879
• Product Code: JXG
• UDI-Device Identifier: 10886704040507
• UDI-Public: (01)10886704040507(17)231031(10)3303152
• Combination Product (Y/N): N
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• 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): 08/09/2022

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: 10/31/2023
• Device Model Number: 82-1621
• Device Catalogue Number: 821621
• Device Lot Number: 3303152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 06/07/2022; 07/21/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/18/2022; 06/22/2022; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 20 KG