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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
Event Date 03/01/2015
Event Type  Injury  
Event Description

It was reported that the patient has been hospitalized recently for various issues including seizures, coma, and pneumonia. Patient also experienced trauma when the paramedics had dropped patient on the floor. It was also reported that the patient had some issues with his vns. Additional information was received that the patient experienced seizure after seizures and later woke up to find himself at the hospital with a ventilation tube. Patient experienced pneumonia from the ventilator. When the ventilator tubes were taken out, it caused his throat to be sore and very sensitive. Patient¿s face was reported to turn purple with stimulation which was reported to have resolved on its own. Patient also experienced increased heart rate with stimulation following this incident. It is unknown if this event started recently after the hospitalization or if it was present before. Patient was recommended to visit the neurologist regarding this. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

Additional information was received that the patient was having issues with throat closing and tachycardic episodes with stimulation (hr 130) with some recent change in settings on an unknown date. The patient's generator interrogated and found to be with settings of 1. 75/30/500/30/3. 0. The patient's frequency was lowered to 20 hz, which appeared to resolve the issue and the stimulation was still tolerable. At that time the physician was going to monitor the patient to ensure there were no other issues. The impedance was also confirmed to be 3115 ohms with no other issues with the device.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4698228
Report Number1644487-2015-04475
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 03/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2014
Device MODEL Number103
Device LOT Number202378
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/11/2013
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: 04/16/2015 Patient Sequence Number: 1
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