MAUDE Adverse Event Report: VP SHUNT; NEUROLOGICAL TRAY

Device Problems Inaccurate Flow Rate (1249); Nonstandard Device (1420); Device Damaged by Another Device (2915)

Patient Problems Dyspnea (1816); Headache (1880); Sleep Dysfunction (2517)

Event Date 11/14/2022

Event Type  Injury  

Event Description

(b)(6) is a 12 yo male.He is non-verbal.Something was bothering him and we could not figure it out.(b)(6) has hydrocephalus with a vp shunt.The rt informed us that the mask was recalled due to the magnetic device potentially causing harmful side effects.After further a valuation, it was determined that the youth wisp nasal mask change (b)(6) vp shunt shutting causing his csf fluid to drain at a faster rate causing low pressure headaches.The pain was so intolerable it caused diminished breathing, inability to sit-up and sleeping excessively.

• Brand Name: VP SHUNT
• Type of Device: NEUROLOGICAL TRAY
• MDR Report Key: 16043167
• MDR Text Key: 306205924
• Report Number: MW5113965
• Device Sequence Number: 2
• Product Code: OJG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/06/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Patient Sequence Number: 1
• Treatment: 9% SALINE; BETHKIS; CALCIUM; CAYSTON; DIAMOX; HILL ROM VEST; HYPERTONIC SALINE; KEPPRA; LEVOCARNITINE; MIRALAX; NEBULIZER MACHINE; PULMOZYME; SIMETHICONE DROPS; SOTALOL; SUCTIONER; TRILOGY EVO AVAP; VITAMIN D; XOPONEX
• Patient Outcome(s): Hospitalization
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 39 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White