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

Model Number	82-1621
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Vomiting (2144)
Date of Event	08/21/2020
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: in a studcln2, 2, the patient received intraventricular enzyme therapy via rickham reservoir every 14 days.After the intraventricular therapy on (b)(6) 2020, the patient developed fever and vomiting.After liquid analysis, the diagnosis of a bacterial rickham infection with micrococcus species was made in an external hospital.Antibiotic therapy and explantation of the reservoir was done.Following antibiotic therapy, the patient's parents discontinued enzyme replacement therapy.Patient recovered.
Additional Manufacturer Narrative
Additional information received: - in 2019 the patient initiated treatment with brineura for the indication of neuronal ceroid lipofuscinonsis.The most recent dose was administrated on (b)(6) 2020.- on (b)(6) 2020, infection was detected.- the treatment was : vancomycin and cefotaxime sodium for 14 days with surgical removal of reservoir.- the outcome of the event was reported as resolved and it was noted that the infection healed without sequelae.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Rickham reservoir was not returned for evaluation (discarded); 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 patient developed fever and vomiting¿ reported by the customer, could be linked to the patient and hospital surroundings as the review of the sterilization certificate was conform to specifications when released.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; the reporter assessed the event of device related infection as unknown in relation to treatment with brineura.The reporter did not provide an assessment of the event of device related infection in relation to the patient's icv device.No other etiological factors were reported.No further information was available.Case comment: the patient experienced device related infection, which is a known complication of icv device use.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: 13861658
• Report Number: 3013886523-2022-00099
• Device Sequence Number: 4691881
• Product Code: JXG
• UDI-Device Identifier: 10886704040507
• UDI-Public: (01)10886704040507(17)230430(10)195997
• 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,Followup,Followup
• Report Date (Section B): 08/16/2022

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: 04/30/2023
• Device Model Number: 82-1621
• Device Catalogue Number: 821621
• Device Lot Number: 195997
• 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; 05/19/2022; 07/21/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/18/2022; 06/07/2022; 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2018
• 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
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 30 KG