MAUDE Adverse Event Report: RAYNHAM VENT RES TR RICKHAM ST BA; RESERVOIRS

Model Number 82-1621

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2023

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

Hold rh 2.22.23 study: 6 year-old female patient.(b)(6) study: (b)(6)."the subject's past medical history was not reported.The subject's concurrent conditions included: csf lymphocyte count increased, neuronal ceroid lipofuscinosis, constipation, carnitine decreased and epileptic encephalopathy.No allergies were reported.Concomitant medication included: clobazam, levocarnitine hydrochloride, "chlorhexidine gluconate", colecalciferol, docusate sodium, ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate, choline chloride, chromic chloride, colecalciferol, copper sulfate, dl-alpha tocopheryl acetate, fats nos, ferrous sulfate, folic acid, inositol, levocarnitine, magnesium phosphate, manganese sulfate, nicotinamide, phytomenadione, potassium chloride, potassium hydroxide, potassium iodide, proteins nos, pyridoxine hydrochloride, retinol palmitate, riboflavin, sodium molybdate, sodium selenate, taurine, thiamine hydrochloride, vitamin b12 nos, zinc sulfate, macrogol 3350, valproate semisodium, pyridoxine hydrochloride, levetiracetam and diazepam.Paracetamol, lidocaine/prilocaine and cetirizine hydrochloride were used as premedication for the subject's brineura infusions." on (b)(6) 2020, the subject underwent implantation of intracerebral ventriculostomy (icv) set, (codman holter rickham reservoir - 6 millimeter).The lot number was 4267695.The operator of the icv device was an unspecified healthcare professional.On (b)(6) 2020, the subject initiated treatment with brineura (300 milligram, qow, intracerebroventricular).The lot number for brineura was not reported.The most recent dose was administered on (b)(6) 2021.On (b)(6) 2023 at 15:00, the subject experienced device end of life - replacement (device end of service).The severity of the event was not reported.No laboratory or diagnostic tests were reported.On (b)(6) 2023, the subject was hospitalized where treatment included removal and replacement of the device.No action was taken with brineura 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 end of service as not related to treatment with brineura.No other etiological factors were reported.The outcome of the event was updated from recovering/resolving to recovered/resolved on january 23, 2023.Other etiological factors included it was related to the device.Case comment: icv device was prophylactically replaced due to end of life cycle of device.It is usually due to material degradation of device because of long periods of use.The causality of event is assessed as not related to brineura.

Event Description

N/a.

Manufacturer Narrative

The rickham reservoir (id 821621) 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.

Manufacturer Narrative

Additional information received 11/21/2023 2:33 am: the subject's past medical history included two episodes of covid-19.Additional concomitant medication included factor viii (antihaemophilic factor)/ von willebrand factor.The lot number for brineura was l241230.Other relevant history: # start/stop date: condition type / condition.* (b)(6) 2021 to (b)(6) 2021 - historical condition covid -19.* (b)(6) 2022 to (b)(6) 2022 - historical condition covid -19.Concomitant medical products and therapy dates: humate-p (factor viii (antihaemophilic factor), von willebrand factor) (b)(6) 2023 to (b)(6) 2023.

Event Description

N/a.

• Brand Name: VENT RES TR RICKHAM ST BA
• Type of Device: RESERVOIRS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16409804
• MDR Text Key: 309980275
• Report Number: 3013886523-2023-00045
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704040507
• UDI-Public: (01)10886704040507
• Combination Product (y/n): N
• PMA/PMN Number: K102961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 82-1621
• Device Catalogue Number: 821621
• Device Lot Number: 4267695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2023
• Date Device Manufactured: 12/04/2019
• 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: 14) HUMATE-P (FACTOR VIII (ANTIHAEMOPHILIC FACTOR); ACETAMINOPHEN (PARACETAMOL) 01/27/2021 TO ONGOING; CLOBAZAM (CLOBAZAM) 04/27/2021 TO ONGOING; COLACE (DOCUSATE SODIUM) 10/05/2021 TO ONGOING; DEPAKOTE SPRINKLE (VALPROATE SEMISODIUM); DIASTAT (DIAZEPAM; EMLA (LIDOCAINE, PRILOCAINE) 03/18/2020 TO ONGOING; KEPPRA (LEVETIRACETAM); LEVOCARNITINE HYDROCHLORIDE TO ONGOING; MIRALAX (MACROGOL 3350) 01/11/2022 TO ONGOING; PEDIASURE GROW & GAIN 04/12/2021 TO ONGOING; VITAMIN B-6 (PYRIDOXINE HYDROCHLORIDE); VITAMIN D3 (COLECALCIFEROL) 11/15/2022 TO ONGOING; ZYRTEC (CETIRIZINE HYDROCHLORIDE)
• Patient Age: 6 YR
• Patient Sex: Female