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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS VNS MAGNET MODEL 220 VAGUS NERVE STIMULATOR

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CYBERONICS VNS MAGNET MODEL 220 VAGUS NERVE STIMULATOR Back to Search Results
Model Number (11)150331
Event Date 08/19/2016
Event Type  Injury  
Event Description

Cyberonics vns magnet model 220 implant on (b)(6) 2016. (b)(6) 2016 device short circuited causing potential damage to vagal nerve. Patient felt extreme heat and could not move for 24 hours. Device then shut off, had to be surgically removed and replaced on (b)(6) 2016. Picture of malfunction device shows bubble that formed to interfere with wires. Device sent back to cyberonics. Lot number 1464006.

 
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Brand NameVNS MAGNET MODEL 220
Type of DeviceVAGUS NERVE STIMULATOR
Manufacturer (Section D)
CYBERONICS
MDR Report Key7424951
Report NumberMW5076446
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation UNKNOWN
Report Date 04/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date04/30/2018
Device MODEL Number(11)150331
Device LOT Number1464006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/11/2018 Patient Sequence Number: 1
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