Wednesday, August 17, 2011

The device in question is a Vagus Nerve Stimulator that is implanted within the patient to give electrical stimulation to the Vagus Nerve. The Vagus Nerve is one of the longest nerves in the body, running from the brain to the heart and down to the abdomen. This is a fairly new device and is being used to treat everything from epilepsy to depression.

Funny, the patient who reported problems with the VNS device had many of the same symptoms I have complained about --

Electrical current/shock sensations through body--from heart down to abdomen.

MAUDE Adverse Event Report

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CYBERONICS DEMIPULSE CYBERONICS VNS PULSE GENERATOR Back to Search Results
Event Date 01/05/2011
Event Type No Answer Provided
Event Description
Explantation of cyberonics vns demipulse model 103 from left upper anterior chest due to malfunction. Patient reported shock-like sensation on the site extending up to the neck and down to left arm and left upper abdomen. Patient did not experience permanent harm.


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Brand Name DEMIPULSE
Type of Device CYBERONICS VNS PULSE GENERATOR
Manufacturer (Section F)
CYBERONICS
100 Cyberonics Blvd.
Houston TX 77058
Manufacturer (Section D)
CYBERONICS
100 Cyberonics Blvd.
Houston TX 77058
Device Event Key 2092423
MDR Report Key 2061420
Event Key 1958396
Report Number 2061420
Device Sequence Number 1
Product Code LYJ
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/08/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 04/07/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Physician
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA 04/07/2011
Event Location Hospital
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 04/07/2011 Patient Sequence Number: 1
# Treatment Treatment Date
1,NOT KNOWN

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