MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICULAR CATHETER WITH BIOGLIDE, STANDARD, 23 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	91503
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2020
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 the patient was implanted with an adjustable pressure shunt on (b)(6) 2019 due to hydrocephalus.In (b)(6) 2020, the patient's family found the pressure regulator valve implanted was originally above the cochlea, but now, the position of the pressure regulator valve slipped below the cochlea.The family contacted the surgeon to inform the doctor of the situation of the valve displacement, and the surgeon stated that they could not judge the situation of the patient by the phone.It was recommended that the patient undergo a local ct examination and confirm follow-up treatment plan based on the results of the examination.The patient was at home without any discomfort.Additional information received reported that the patient was too young and relatively live and active resulting in the loosening of the interface between the valve and the ventricular end.The doctor reconnected the valve through surgery and informed them about postoperative precautions.

• Brand Name: VENTRICULAR CATHETER WITH BIOGLIDE, STANDARD, 23 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9802167
• Report Number: 2021898-2020-00092
• Device Sequence Number: 609735
• Product Code: JXG
• UDI-Device Identifier: 00643169466289
• UDI-Public: 00643169466289
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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: 02/28/2023
• Device Model Number: 91503
• Device Catalogue Number: 91503
• Device Lot Number: E46977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/06/2020
• 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: 4 MO
• Patient Weight: 7