MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD UNKNOWN RICKHAM RESEVOIR; RESERVOIRS

Catalog Number XXX-RICKHAM RESEVOIR

Device Problem Insufficient Information (3190)

Patient Problem Erythema (1840)

Event Date 02/04/2024

Event Type  Injury  

Event Description

Medwatch us-2024-155826.Study - this case is a report referring to a 10 year old male patient.An investigator reported this case from the biomarin study, cerliponase alfa observational study.The patient's past medical history included: covid-19 and medical device implantation.The patient's concurrent conditions included: head titubation, drooling, infection, neuronal ceroid lipofuscinosis, seizure, constipation, abdominal discomfort, reflexes abnormal, urinary incontinence, hearing disability and muscle atrophy.No allergies were reported.Concomitant medication included: clobazam, diazepam, phenobarbital, macrogol 3350, nutrients nos, clonazepam, omeprazole magnesium, perampanel, topiramate and amoxicillin trihydrate.Lidocaine hydrochloride, paracetamol, ondansetron hydrochloride and cetirizine hydrochloride were used as premedication for the participant's infusions.On (b)(6) 2018, the patient underwent implantation of intracerebral ventriculostomy (icv) set (device reported as generic rickham; model and lot number were not reported).On (b)(6) 2018, the patient initiated treatment with brineura (300 milligram, qow, intracerebroventricular use).The lot number for brineura was l241247.The most recent dose was administered on (b)(6) 2024.On (b)(6) 2024, the patient went to the emergency department (ed) for skin redness that was lateral to the ventricular assist device (vad) site but not over the vad site after getting his brineura infusion on february 2nd.He had mild erythema at the injection site.Results of a cerebrospinal fluid (csf) culture were negative.The neurosurgery department recommended that he be admitted to the hospital.On (b)(6) 2024, the patient was hospitalized with grade 3 folliculitis.The patient was started on intravenous cefazolin sodium and improved.Additional laboratory tests taken on an unspecified date included: a negative blood culture, normal metabolic function test, wbc 6.9 and crp <5 (units and normal values not reported for all tests).No action was taken with brineura due to the event.The outcome of the event was reported as recovered/resolved on (b)(6) 2024.The participant was discharged on the same date with a ten-day course of cefalexin.The investigator assessed the event of folliculitis as not related to treatment with brineura.The investigator assessed the event of folliculitis as related to the icv device.No other etiological factors were reported.Case comment: patient experienced folliculitis near to icv device site.The event is related to icv device use.The causality of event is assessed as not related to brineura.

Manufacturer Narrative

Rickham reservoir 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 issue 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: UNKNOWN RICKHAM RESEVOIR
• Type of Device: RESERVOIRS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18839383
• MDR Text Key: 336960681
• Report Number: 3013886523-2024-00057
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-RICKHAM RESEVOIR
• Date Manufacturer Received: 02/16/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN (PARACETAMOL); AMOXICILLIN (AMOXICILLIN TRIHYDRATE); BOOST KID ESSENTIALS 1.5 (NUTRIENTS NOS); CETIRIZINE (CETIRIZINE HYDROCHLORIDE); CLOBAZAM; CLOBAZAM; CLOBAZAM; DIASTAT ACUDIAL (DIAZEPAM); EPRONTIA (TOPIRAMATE); FYCOMPA (PERAMPANEL); KLONOPIN (CLONAZEPAM); LIDOCAINE HCL (LIDOCAINE HYDROCHLORIDE; MIRALAX (MACROGOL 3350); OMEPRAZOLE (OMEPRAZOLE MAGNESIUM); ONDANSETRON (ONDANSETRON HYDROCHLORIDE); PERAMPANEL (PERAMPANEL); PHENOBARBITAL; PHENOBARBITAL; TOPIRAMATE (TOPIRAMATE); TOPIRAMATE (TOPIRAMATE)
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 83