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	08/18/2020
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; patient is receiving intraventricular enzyme replacement therapy via a rickham reservoir.After the intraventricular therapy on (b)(6) 2020, the patient developed fever and vomiting.The diagnosis of a bacterial rickham infection with staph epidermidis was made in the csf analysis.Antibiotic therapy and explantation of the reservoir followed.Following antibiotic therapy, a new reservoir was reimplanted.Patient recovered.
Additional Manufacturer Narrative
Additional information received: on (b)(6) 2019, the patient underwent implantation of an intracerebral ventriculostomy (icv) set (rickham; model not reported).On an unspecified date, the patient initiated treatment with brineura (300 milligram, qow, icv) for the indication of neuronal ceroid lipofuscinosis.The most recent dose was administered on (b)(6) 2020.On (b)(6) 2020, following the patient's brineura infusion, he developed a fever and vomiting.The patient was hospitalized and during a 24-hour monitoring period, he exhibited reduced general condition, was whiny, sensitive to touch, and had possible neck stiffness.On (b)(6) 2020, the patient's cerebral spinal fluid (csf) was tested, showing 11200/3 cells and protein total was 1016 mg/l.Culture of the csf revealed infection with staph epidermis.The subject was diagnosed with ventriculitis/infection staphylococcal and device related infection.Treatment with a 14-day cycle of vancomycin and cefotaxime sodium was started and the rickham reservoir was subsequently replaced.Treatment with brineura was held due to the event.The reporter assessed the event as medically significant.The outcome of the event was reported as recovered/resolved on an unreported date.On (b)(6) 2020, a new icv reservoir was placed.The reporter did not provide an assessment of the event of cns ventriculitis in relation to treatment with brineura or the icv device.No other etiological factors were reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 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 ¿fever and increasing tiredness ¿ 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.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information received: the reporter's assessment of the event of cns ventriculitis was updated from not reported to unknown in relation to treatment with brineura.No other etiological factors were reported.No further information was available.Case comment: the patient experienced device related infection and cns ventriculitis, which are a known complication of icv device use.The causality of event is assessed as not related to brineura.

• 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: 13861811
• Report Number: 3013886523-2022-00101
• Device Sequence Number: 14792000
• 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
• 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; 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; 08/09/2022
• 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): 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: 24 KG