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Catalog Number 821616
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Headache (1880); Vomiting (2144)
Event Type  Injury  
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 Description
Study: (b)(6)-year-old male with mucopolysaccharidosis type iiib enrolled in: a (b)(6) study to evaluate the long-term safety and efficacy of intracerebroventricular ax 250 in patients with mucopolysaccharidosis type iiib (mps iiib, sanfilippo syndrome type b). Study treatment with ax 250 was initiated on (b)(6) 2018. The subject's most recent dose of ax 250, received prior to the sae and eosi onset, was on (b)(6) 2021. The subject's relevant medical and surgical history included recurrent bronchitis, recurrent ear, nose and throat (ent) infections, hearing impairment, speech delay, hepatomegaly, abnormal facial features, developmental delay, short neck, recurrent glue ear, splenomegaly and sleep disturbances. Relevant concomitant medications taken within 14 days of sae and eosi onset included cetirizine, paracetamol, nystatin, risperidone (risperdal) and cannabidiol. Previously reported sae/eosis for this subject included increased resistance during study drug infusion + slight swelling around rickham reservoir on (b)(6) 2018 ((b)(4)), device dysfunction on (b)(6) 2018 ((b)(4)), staphylococcus hominis in csf on (b)(6) 2018 ((b)(4)), extravasation of ip/csf on (b)(6) 2018 ((b)(4)), intracerebroventricular infection on (b)(6) 2019 ((b)(4)) and intracerebroventricular infection on (b)(6) 2019 (19-de-ax202-00037). On (b)(6) 2021, during the day, the subject felt weak and slept a lot. That evening, the subject began vomiting several times and mentioned headaches. The nausea and vomiting persisted and no diarrhea or fever was present. Due to worsening headache the subject attended the emergency room (er) at around 8 pm. At presentation the subject was clinically stable, awake and responsive. He presented with a headache, nausea and fever with a body temperature of 38. 6 degrees celsius. His vital signs were stable. An intracerebroventricular (icv) puncture was performed and the puncture site was slightly reddish. The cerebrospinal fluid (csf) status showed an increased cell count of 1074/3 cells (normal range [nr] <12/3 cells), increased lactate 3. 2 mmol/l (nr 0. 5-2. 2 mmol/l) and increased protein 356 mg/l (nr 80-320 mg/l). Laboratory tests also revealed mild leukocytosis, 15. 9 mrd/l (nr 4. 5-13. 5 mrd/l). A csf culture was drawn which revealed staphylococcus epidermidis. The subject was hospitalized due to intracerebroventricular infection. The event was considered medically significant and was an adverse event of special interest. Treatment for the event included vancomycin, cefotaxime and paracetamol. Due to the subject¿s agitation during blood draws the subject received treatment with lorazepam. On (b)(6) 2021, the rickman catheter explantation occurred without complications. The subject received sufentanil, propofol and cisatracurium for anesthesia and ibuprofen, midazolam and sterofundin perioperatively. The subject was in good condition, was afebrile and the wound was dry, free from irritation and no liquor pillow was palpable. The event was ongoing and the subject remained hospitalized. On an unspecified date, study drug was interrupted. De-challenge information was not provided. The investigator assessed the intracerebroventricular infection as nci ctcae grade 3 in severity and not related to study drug. The investigator assessed the intracerebroventricular infection as related to the non-study device. The sponsor assessed the intracerebroventricular infection as nci ctcae grade 3 as not related to study drug. The sponsor assessed the intracerebroventricular infection as related to non-study device. Suspect products: ax 250 (ax 250) solution for infusion - 300 milligram, weekly, icv infusion. Diagnosis for use: :mucopolysaccharidosis iii (mucopolysaccharidosis iii). Lot: 251017, 251048. Non-study device (non-study device) n/a. Diagnosis for use: :mucopolysaccharidosis iii (mucopolysaccharidosis iii). Lot 131335 (exp 03/31/2022). Concomitant medical products and therapy dates: cetirizin (cetirizine hydrochloride), paracetamol (paracetamol) , nystatin (nystatin), risperdal (risperidone), cannabidiol (cannabidiol).
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Type of DeviceRESERVOIRS
Manufacturer (Section D)
11 cabot boulevard
11 cabot boulevard
mansfield MA
Manufacturer (Section G)
11 cabot boulevard
mansfield MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
MDR Report Key11815842
MDR Text Key265476006
Report Number3013886523-2021-00217
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number821616
Device Lot Number4108600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown