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

Model Number	821623
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical study ( biomarin sponsored study, cerliponase alfa observational study): this case is a report referring to a 7 years-old male subject.On (b)(6) 2018, the subject underwent implantation of codman rickham icv device (model 82-1623).The lot number and serial number were not reported.On (b)(6) 2018, the subject initiated treatment with brineura (300 milligram, qow, intracerebroventricular).The lot number for brineura was l241207.The most recent dose was administered on (b)(6) 2022.On (b)(6) 2022 at 10:00, the subject experienced grade 1 device related infection (device related infection).On (b)(6) 2022, the subject had a csf culture collected that revealed rare white blood cells and no organisms seen.The positive csf result was confirmed on (b)(6) 2022 when the csf culture revealed rare gram in thioglycolate broth only.The device was no replaced and no treatment was given.No action was taken with brineura due to the event.The outcome of the event was reported as recovering/resolving.Biomarin has assessed the event as medically significant.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 related to the icv device.No other etiological factors were reported.Additional information has been requested and, if received, the report will be updated.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.
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
N/a.
Additional Manufacturer Narrative
The rickham valve 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, the possible root cause for the ¿infection¿ reported by the customer, could be linked to the patient and hospital surroundings.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.

• Brand Name: VENT RES TR RICKHAM LG 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: 15545945
• Report Number: 3013886523-2022-00462
• Device Sequence Number: 14851149
• 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
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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 Model Number: 821623
• Device Catalogue Number: 821623
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 04/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLOBAZAM (ONGOING); CYPROHEPTADINE; CYPROHEPTADINE (ONGOING); DIASTAT ACUDIAL (ONGOING); DIAZEPAM; EMLA (ONGOING); LIDOCAINE (ONGOING); MIRALAX (ONGOING); ONDANSETRON (ONGOING); ZONISAMIDE (ONGOING)
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 40 KG