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

Model Number	821625
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch (b)(4).Study: 12 month-old female patient.This case was reported by a physician.The patient's past medical history was device malfunction and medical device adjustment.The patient's concurrent conditions were neuronal ceroid lipofuscinosis.No allergies were reported.No concomitant medications were reported.On (b)(6) 2022, the patient underwent implantation of intracerebral ventrisculostomy (icv) set (codman rickham; model number not reported).The lot number was 6406334.On (b)(6) 2022, the patient initiated treatment with brineura (200 milligram, qow, intracerebroventricular use) for the indication neuronal ceroid lipofuscinosis.The lot number for brineura was not reported.The most recent dose was administered on an unreported date.On (b)(6) 2022, there was concern for ongoing catheter misplacement despite recent icv reservoir revision.The team was assessing whether there was an issue with the catheter via imaging and consultation with neurosurgery.At the time of this report, the patient was awaiting neuroimaging under sedation.On (b)(6) 2022, there were two unsuccessful attempts to access the icv reservoir, with scant blood return each time (csf red blood cell count positive).No other signs or symptoms were noted.No laboratory or diagnostic tests were reported.No treatment for the event was reported.On (b)(6) 2022, treatment with brineura was held due to the event.The outcome of the event was not reported.The reporter did not provide an assessment of the event of csf red blood cell count positive in relation to treatment with brineura.The reporter assessed the event of csf red blood cell count positive as related to the icv device.According to the reporter, other etiological factors included that the event was a complication of the device, not brineura.No further information is expected.Case comment: patient experienced csf red blood cell count positive after two unsuccessful attempts to access the icv reservoir, with scant blood return each time.This is a known complication of icv device use.The causality of 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 field: d4, d9, g3, g6, h2, h3, 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 or Problem Description
N/a.

• Brand Name: VENT RES TR SAL-RIC ST BA
• Common Device Name: 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: 16104473
• Report Number: 3013886523-2022-00590
• Device Sequence Number: 7636412
• Product Code: JXG
• UDI-Device Identifier: 10381780517795
• UDI-Public: (01)10381780517795(17)270430(10)6406334
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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 Model Number: 821625
• Device Catalogue Number: 821625
• Device Lot Number: 6406334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 04/27/2023
• Date Device Manufactured: 05/31/2022
• 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
• Patient Age: 12 YR
• Patient Sex: Unknown