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: case description: this case is referring to an approximately 7 year-old male participant.An investigator reported this case from the biomarin study, cerliponase alfa observational study." the participant's past medical history was not reported.The participant's concurrent conditions included epilepsy, gastrooesophageal reflux disease, vomiting, behaviour disorder, neuronal ceroid lipofuscinosis and sleep disorder.No allergies were reported." "on an unreported date, the participant underwent implantation of intracerebral ventriculostomy (icv) set (manufacturer unknown).The lot number was not reported." "on (b)(6) 2024, the participant initiated treatment with brineura (300 milligram, qow, intracerebroventricular).The lot number for brineura was not reported.The most recent dose of brineura was administered on (b)(6) 2024." on (b)(6) 2024 the participant received their brineura infusion and there was no pleocytosis present at that time and a cerebrospinal fluid (csf) culture became positive for gram positive cocci in clusters.On (b)(6) 2024 at 13:15, the participant experienced grade 3 device related infection (device related infection).On the same date, the participant started vomiting without having a fever.The participant was presented and found to have significant pleocytosis for which he was admitted and started on unspecified antibiotics as treatment for the event.On (b)(6) 2024 the participant's csf culture became positive for gram positive cocci clusters, and further determination was to follow.The participant's reservoir would likely need to be removed which would lead to the participant missing at least one brineura infusion.No additional treatment for the event was reported.On an unreported date, treatment with brineura was held due to the event." "the outcome of the event was reported as recovering/resolving." "the investigator assessed the event of device related infection as not related to treatment with brineura.No other etiological factors were reported." additional information received on 04-mar-2024: "the participant was again started on antibiotics and vancomycin locks in their reservoir as treatment for the event.On (b)(6) 2024, the participant had his reservoir removed as the csf culture remained positive.The participant was to be treated for an additional 7 days with antibiotics and was scheduled for a new reservoir to be implanted shortly.Antibiotics and additional treatment for the event were noted to be granisetron hydrochloride, meropenem trihydrate, vancomycin hydrochloride, ceftriaxone sodium, macrogol, flucloxacillin, cefazolin, diclofenacum natricum, morphine, and ibuprofen." "the outcome of the event was updated from recovering/resolving to recovered/resolved on (b)(6) 2024 at 13:50." additional information received on 14-mar-2024: "on (b)(6) 2023, the participant underwent implantation of intracerebral ventrisculostomy (icv).The lot and model number were reported as 82-1616 and the udi# was ean (b)(4).On (b)(6) 2024, the device was removed but was not available to be returned." no further information was available.Medwatch: mfr report #: (b)(4).
Additional Manufacturer Narrative
The holter rickham reservoir was not returned for evaluation (study) 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.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: 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: 19091174
• Report Number: 3013886523-2024-00107
• Device Sequence Number: 18067026
• Product Code: JXG
• UDI-Device Identifier: 10381780517733
• UDI-Public: 10381780517733
• Combination Product (Y/N): N
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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 Catalogue Number: 821616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/11/2024
• 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 FUMARATE); CLOBAZAM (CLOBAZAM); CLOBAZAM (CLOBAZAM); DEXAMETHASON (DEXAMETHASONE); DEXAMETHASON (DEXAMETHASONE); DEXAMETHASONE (DEXAMETHASONE PHOSPHATE); ESOMEPRAZOL (ESOMEPRAZOLE SODIUM); ESOMEPRAZOL (ESOMEPRAZOLE SODIUM); HYDROXYZINE (HYDROXYZINE); LACOSAMIDE (LACOSAMIDE); LAMOTRIGINE (LAMOTRIGINE); LAMOTRIGINE (LAMOTRIGINE); LEVETIRACETAM (LEVETIRACETAM); MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE); MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE); MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE); MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE); PARACETAMOL (PARACETAMOL); PARACETAMOL (PARACETAMOL); PARACETAMOL (PARACETAMOL); PARACETAMOL (PARACETAMOL); PARACETAMOL (PARACETAMOL); PARACETAMOL (PARACETAMOL); PARACETAMOL (PARACETAMOL); PARACETAMOL (PARACETAMOL); PARACETAMOL (PARACETAMOL) 07/15/2022 TO ONGOING; PIPAMPERONE (PIPAMPERONE); VALPROATE (VALPROATE SODIUM); VITAMIN C; VITAMIN D (VITAMIN D NOS)
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Race: White