MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA CHAMBER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	24053
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a obstructive hydrocephalus patient required a low pressure valve.After the valve and 3 way connector were implanted, they were both found to be leaking.The valve was leaking from the chamber, and the connector was leaking distal or tail end of the y.The patient had the components replaced with a new 3 way connector and valve which was set at 0.5.It was stated that their 4th ventricle obstruction cleared.The patient was now draining well and according to the registrar, they were doing well with no further complications.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that there were no environmental/external/patient factors that may have led or contributed to the issue.
Additional Manufacturer Narrative
The returned device was patent.The delta chamber passed leakage, siphon control, pressure flow characteristics and preimplantation testing.No tears on the delta chamber were evident during visual inspection and no air bubbles were observed during leakage testing therefore the field observations could not be observed by the laboratory personnel.Ifu states that ¿use of sharp instruments while handling these devices can nick or cut the silicone elastomer, resulting in leakage and necessitating shunt revision.Care must be taken when closing incisions to ensure that the valves are not cut or nicked by suturing needles.¿ review of dhr for lot # e70772 did not identify any finding correlated to the complaint.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DELTA CHAMBER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9506263
• Report Number: 2021898-2019-00449
• Device Sequence Number: 1542694
• Product Code: JXG
• UDI-Device Identifier: 00643169466517
• UDI-Public: 00643169466517
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K862907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 24053
• Device Catalogue Number: 24053
• Device Lot Number: E70772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/01/2020; 03/26/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/15/2020; 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR