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

Catalog Number	821623
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The rickham reservoir (id 821623) 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.All finished goods test results, including endotoxin satisfactorily met the requirements.The root cause(s) of the reported issue could not be determined.However, the possible root cause for the ¿infection,¿ reported by the customer, could be linked to the patient and hospital surroundings.However, it was not possible to confirm and identify the root cause of this assumption as the product was not returned for investigation.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
This is 2 of 2 reports linked to mfg report numbers: 3013886523-2023-00348 biomarin study: cerliponase alfa observational study.Case description: this case refers to a 20 year-old male subject."on (b)(6) 2018, the participant underwent implantation of intracerebral ventriculostomy (icv) set codman rickham; model number 82-1623.The lot number was not reported." "on (b)(6) 2024 at 07:40, the participant's cerebrospinal fluid (csf) testing was performed, and rare white blood cells were observed; however, no organism was seen.The participant experienced a grade 1 device related infection.On the same date, vancomycin hydrochloride was given pre-infusion and then the participant had his brineura infusion.On (b)(6) 2024, the csf collected on (b)(6) 2024 tested positive for rare curtibacterium (formerly propionibacterium) acnes.Csf was again collected on (b)(6) 2024 (no results reported) and tested negative on 30-sep-2024.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 26-sep-2024 at 09:12." "the investigator assessed the event of "device related infection" as not related to treatment with brineura.The investigator assessed the event of "device related infection" as most likely related to the icv device since the device was implanted on (b)(6) 2018." case comment: "the patient experienced device related infection, which is a known complication of icv device use.The causality of the event is assessed as not related to brineura.".

• Brand Name: VENT RES TR RICKHAM LG 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: 20524701
• Report Number: 3013886523-2024-00325
• Device Sequence Number: 8078307
• Product Code: JXG
• UDI-Device Identifier: 10381780517788
• UDI-Public: 10381780517788
• 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: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 821623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ACETAMINOPHEN (PARACETAMOL); CETIRIZINE (CETIRIZINE HYDROCHLORIDE); GEMFIBROZIL (GEMFIBROZIL); IBUPROFEN (IBUPROFEN); KEPPRA XR (LEVETIRACETAM); KETOVIE 4:1 (NUTRIENTS NOS); LIDOCAINE HCL (LIDOCAINE HYDROCHLORIDE); ONDANSETRON (ONDANSETRON HYDROCHLORIDE); RIFAMPIN (RIFAMPICIN); TRIHEXYPHENIDYL (TRIHEXYPHENIDYL HYDROCHLORIDE); VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Male