MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HOLTER RICKHAM RES,LGPLAS; RESERVOIRS

Catalog Number	821616
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Event or Problem Description
Study: cerliponase alfa observational study referring to an approximately 5 year-old male subject.The subject's past medical history and procedure included: medical device implantation.The subject's concurrent conditions included: pain, neuronal ceroid lipofuscinosis, sleep disorder, gastrooesophageal reflux disease, and epilepsy.No allergies were reported.Concomitant medication included: vitamin d, midazolam, valproate sodium, lamotrigine, paracetamol, hydroxyzine, and esomeprazol.Premedication included: dexamethasone phosphate and clemastine.On an unreported date, the subject underwent implantation of an intracerebral ventriculostomy (icv) set (codman; model, lot and serial numbers were not reported).On (b)(6) 2021, the subject initiated treatment with brineura (300 milligram, qow, intracerebroventricular).The lot number for brineura was not reported.On (b)(6) 2023, the subject received his brineura administration and there were no clinical abnormalities, no signs of infection, and no signs of leakage from the reservoir.The infusion was given without any problems and the subject had a normal csf count.A csf culture was taken that day and became positive on (b)(6) 2023 with gram positive cocci; staphylococcus epidermidis was cultured.On (b)(6) 2023, the subject was diagnosed with a grade 3 device related infection (device related infection) with symptoms of nausea and apathy.The subject was hospitalized due to the event and was started on unspecified antibiotics as treatment for the event.The subject's rickham reservoir was removed on an unspecified date.Treatment additionally included vancomycin for 7 days after the rickham reservoir was removed and the subject was scheduled to have a new icv device placed.On an unspecified date, treatment with brineura was missed due to the event.The outcome of the event was reported as recovering/resolving.The investigator assessed the event as medically significant.The investigator assessed the event of device related infection as not related to treatment with brineura and related to the icv device.No other etiological factors were reported.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.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, e1, g3, g6, h2, h3, h4, h6, h10 complaint sample 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, however, the possible root cause for the issue reported by the customer, could be linked to the patient and hospital surroundings as the review of the sterilization certificate was conform to specification when released.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.Additional information received: the subject's additional concomitant medications included clobazam, diclofenac sodium, sodium chloride and eropenem trihydrate.Treatment for the event included vancomycin hydrochloride.No further information is expected.
Event or Problem Description
N/a.

• Brand Name: HOLTER RICKHAM RES,LGPLAS
• Common Device Name: 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: 17034614
• Report Number: 3013886523-2023-00168
• Device Sequence Number: 6908877
• Product Code: JXG
• UDI-Device Identifier: 10381780517733
• UDI-Public: (01)10381780517733(17)250131(10)4470362
• 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,Followup
• Report Date (Section B): 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 821616
• Device Lot Number: 4470362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 08/02/2023
• Date Device Manufactured: 02/17/2020
• 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: CLEMASTINE (CLEMASTINE) 02/11/2022 TO ONGOING; DEXAMETHASONE 05/06/2022 TO ONGOING; ESOMEPRAZOL (ESOMEPRAZOL) 04/26/2023 TO ONGOING; HYDROXYZINE (HYDROXYZINE) 12/07/2022 TO ONGOING; LAMOTRIGINE (LAMOTRIGINE) 05/25/2022 TO ONGOING; MIDAZOLAM (MIDAZOLAM) 11/27/2020 TO ONGOING; PARACETAMOL (PARACETAMOL) 04/07/2023 TO 04/07/2023; PARACETAMOL (PARACETAMOL) 07/15/2022 TO ONGOING; VALPROATE (VALPROATE SODIUM) 02/14/2022 TO ONGOING; VITAMIN D (VITAMIN D) --/--/2017 TO ONGOING
• Patient Age: 5 YR
• Patient Sex: Male