MAUDE Adverse Event Report: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Increased Sensitivity (2065); Increased Sensitivity (2065); Swelling (2091); Swelling (2091)

Event Date 01/10/2021

Event Type  Injury  

Event Description

Pt reported that he was implanted with a shunt-like device about 12 years ago for "neurological reasons" after stabbing himself in the neck.Pt stated he began to have the following symptoms a week or two after implantation: stomach swelling, suctioning sensation of his belly button, strange sensations in his tongue and leg, pumping on the side of his head, drainage in his throat, hernia like swelling in groin area and testicles, pressure when trying to achieve a bowel movement.He alleged that women and other people are not able to be in close proximity to him due to this device and what is emits.He is not exactly sure why.He was hospitalized and has had a number of tests such as an mri and ct scan to find out exactly what the device is but he has not received any answers.He is concerned that the device is causing all of these symptoms.

Event Description

Add'l info received on 01/21/2020 from reporter for report number mw5092371.Caller reports experiencing "hyperextension in groin", swelling in abdomen and chest, and is "having the runs.".

Event Description

Additional information received from a reporter on 2/5/2021 for a report number mw5092371.A reporter said the shunt was giving him shocking sensation from the left side of his neck all the way to his shoulder.He also said other people in the facility are getting shocking sensation as well.Reporter said once he was given medication his symptoms are gone.The reporter is currently in the psychiatrist facility for his other symptoms like an outburst, hallucination.He is getting treatment for those conditions as well.

• Brand Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPON
• MDR Report Key: 9610947
• MDR Text Key: 176096576
• Report Number: MW5092371
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/21/2020; 02/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 34 YR
• Patient Weight: 77