MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR VENT RES TR RICKHAM ST BA; RESERVOIRS

Model Number 821621

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 (biomarin sponsored study, cerliponase alfa observational study) medwatch: (bmrn: (b)(4).On (b)(6) 2019, the subject underwent implantation of intracerebral ventriculostomy (icv) set (integra life sciences rickham reservoir 6 mm; model 82-1621).On (b)(6) 2022, the subject was hospitalized for a prophylactic intraventricular device replacement (device end of servcie).The intensity of the event was reported as grade 3.The surgery went as planned with no complications.No laboratory or diagnostic tests were reported.No additional 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.The investigator assessed the event of device end of servcie as not related to treatment with brineura.The investigator assessed the event of device end of servcie as related to the icv device.Other possible etiological factors included the device end of life.Additional information received on 22-aug-2022: the outcome of the event was updated by the investigator from recovering/resolving to recovered/resolved on (b)(6) 2022.No further information was available.Additional information received on 13-sep-2022: the most recent dose of brineura administered was updated from (b)(6) 2021 to (b)(6) 2022.The lot number for brineura was l241215.No further information was available.Case comment: the "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.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The rickham valve id (b)(6) 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.

Event Description

N/a.

• Brand Name: VENT RES TR RICKHAM ST BA
• Type of Device: RESERVOIRS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15544122
• MDR Text Key: 301191060
• Report Number: 3013886523-2022-00454
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780517771
• UDI-Public: (01)10381780517771(17)260630(10)5677259
• 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
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 821621
• Device Catalogue Number: 821621
• Device Lot Number: 4304722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2023
• Date Device Manufactured: 07/15/2021
• 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: ACETAMINOPHEN (ONGOING); CETIRIZINE (ONGOING); CLOBAZAM; CLONAZEPAM (ONGOING); MELATONIN; MIDAZOLAM (ONGOING); MULTIVITAMIN (VITAMINS NOS); ONDANSETRON (ONGOING); ZONISAMIDE
• Patient Age: 6 YR
• Patient Sex: Male