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Study - the case is a report referring to an approximately 10 years-old male subject.An investigator reported this case from the biomarin sponsored study, cerliponase alfa observational study."on an unreported date, the subject underwent implantation of intracerebral ventriculostomy (icv) set (codman [generic] number unreported; model unreported) lot number unreported." "on (b)(6) 2018, the subject initiated treatment with bmn 190 (300 milligram, qow, icv).The lot number for bmn 190 was 4304722.The most recent dose was administered on (b)(6) 2022." "on an unreported date, reported as two weeks ago, a cerebral spinal fluid culture (csf) was taken when ivd was assessed; results were pending.On (b)(6) 2022 at 15:24, the results of the csf culture taken two weeks ago was positive (csf culture positive) for propionibacterium acnes.He was at his neurologic baseline and did not have any fevers or signs of cns infection.On the same day, the subject was hospitalized.The severity of the event was reported as grade 3.Infection disease and neurosurgery was consulted and he was recommended for a transfer to inpatient medicine.Treatment for the event included unspecified intravenous antibiotics and assessment of his intraventricular shunt.No action was taken with bmn 190 due to the event.The action taken with the icv device was not reported." "the outcome of the event was reported as recovering/resolving." "the investigator assessed the event of csf culture positive as not related to treatment with bmn 190.However, the investigator assessed the event as related to the icv device.No other etiological factors were reported." additional information received on (b)(6) 2022: "the primary event term, previously reported as positive csf result (csf culture positive), was updated by the investigator to device related infection (device related infection)." "treatment for the event included ceftriaxone." "the investigator assessed the event of device related infection as not related to treatment with brineura.However, the investigator assessed the event as related to the icv device." additional information received on (b)(6) 2022: "additional medical history included central nervous system infection.On (b)(6) 2021, the subject underwent implantation of an intracerebral ventriculostomy (icv) set (codman rickham; model 82-1623), lot number 4304722." "the subject had presented with propionibacterium central nervous system infection of his icv device.The subject had been otherwise well and did not have fevers, vomiting, diarrhea, neck stiffness, "ams", or increased seizure activity.At his baseline examination his catheter site had a small puncture from recent access but no swelling, edema, erythema, induration, or drainage.The subject began vancomycin and additional unspecified tests were to be performed.On an unspecified date, an additional csf culture was taken and results were pending.The patient continued his bmn 190 infusions every two weeks.The csf culture from (b)(6) 2022 came back positive for propionibacterium.The subject's mother reported that he was neurologically at baseline except for mild irritability over the week and that his wound had healed well." "the investigator has assessed the event as medically significant." additional information received on (b)(6) 2022: "the outcome, initially reported as recovering/resolving has been updated to recovered/resolved on (b)(6) 2022 at 11:00." additional information received on (b)(6) 2023: "the onset date, previously reported as (b)(6) 2022 at 15:24 has been updated to (b)(6) 2022 at 15:24." case comment: "the patient experienced csf culture positive for propionibacterium acnes, which is a known complication of icv device use.Propionibacterium acnes are skin commensal bacteria and can cause internal infection following icv device implantation or use.The causality of event is assessed as not related to brineura.Additional information received.The primary event term, previously reported as positive csf result, was updated by the investigator to device related infection.Device related infection is a known complication of icv device use.The causality of event is assessed as not related to brineura.".
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Rickham valve (id 821623) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.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.
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Additional information: on an unspecified date, the subject underwent implantation of intracerebral ventriculostomy (icv) set (codman rickham; model 82-1623), lot number 4975050.On (b)(6) 2018, the subject initiated treatment with brineura (300 milligram, qow, intracerebroventricular use).The lot number for brineura was unknown.The most recent dose was administered on (b)(6) 2023.On (b)(6) 2021, the subject had a positive csf culture of rare cutibacterium species which resulted in the removal and replacement of the device after treatment with antibiotics.On (b)(6) 2022, the subject had a positive csf culture of cutibacterium acnes - gram positive rods which resulted in the removal and replacement of the device after treatment with antibiotics.The most recent icv implantation occurred on (b)(6) 2023.On (b)(6) 2023 at 09:08 the subject had a csf culture performed.On (b)(6) 2023 at 14:14, the results of the culture were a positive csf culture (csf culture positive) with micrococcus luteus critical value.The intensity of the event was reported as grade 2.The subject had been afebrile and well appearing with no change from baseline.The subject was reassessed under sterile conditions and a new csf sample was collected on (b)(6) 2023 which was sent for repeat cultures.Upon the returned results, it will be determined if it is a contaminant.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 recovering/resolving.Biomarin has assessed the event as medically significant.The investigator assessed the event of csf culture positive as not related to treatment with brineura.The investigator assessed the event of csf culture positive as related to the icv device.No other etiological factors were reported.Case comment: the patient experienced csf culture positive for cutibacterium acnes, which is a known complication of icv device use.Cutibacterium acnes are skin commensal bacteria and can cause internal infection following icv device implantation or use.The causality of event is assessed as not related to brineura.
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