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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/20/2018
Event Type  Injury  
Event Description

It was reported that the patient went to the emergency room due to pain shooting up her neck and back of her head that had been occurring for a few hours. The patient also had spasms and twitching on the left side of her body. The physician wanted to disable the device, so instructions on how to use the magnet to disable it were given. The patient was then admitted to the icu and intubated due to unknown reasons, and it was reported that most of the patient's seizures were pseudo-seizures. The physician stated that the patient was reporting that her vns was misfiring, but he did not seem to believe the patient based on her report of false seizures. Because the patient had no insurance or following neurologist, the physician requested that the device be programmed off until it could be properly managed. No further relevant information has been received to date.

 
Event Description

It was reported that the patient was found at a bus stop in status, so she was hospitalized. The patient's device was communicated with, and everything was within normal limits. The physician did not believe the status episode was related to vns as the eeg showed no true seizure activity. The patient's device was functioning as intended. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7343586
Report Number1644487-2018-00410
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/11/2016
Device MODEL Number103
Device LOT Number203094
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/20/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/15/2018 Patient Sequence Number: 1
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