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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/14/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported the patent had experienced obstructive sleep apnea related to vns. The physician explained that the vns settings were decreased and the obstructive sleep apnea resolved. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Clinic notes from three of the patient's office visits were later received. The clinic notes showed that the vns was working as intended as diagnostics results were ok. The notes also showed the patient was having trouble breathing when the device stimulates and the vns settings were adjusted for tolerability. The next set of notes speaks to the patient¿s severe headaches, poor sleep, and dyspnea on exertion, all worsening since the vns implant. The patient was unable to catch her breath after just a brief walk from the waiting room to the exam room, and her breathing had a very airy quality during the entire stimulation period. A fluoroscopic evaluation of the diaphragm movement was arranged and observed. No asymmetry of diaphragmatic movement was noted despite obvious dyspnea during the study. A bedside swallow test of water both between and during stimulation showed increase effort during stimulation, but no choking or aspiration. The integrity of the phrenic nerve function was confirmed, but dyspnea and dysphagia continued; therefore the vns frequency was turned down and the symptoms mostly resolved. The following notes showed the patient¿s seizures were half as frequent now. It was also explained that the patient has had headaches for years, which started after her aneurysm, and continue to get worse as she gets older.

 
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Brand NamePULSE GEN MODEL 106
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 Key6439990
Report Number1644487-2017-03502
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/29/2017
Device MODEL Number106
Device LOT Number203831
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/30/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/20/2016
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: 03/28/2017 Patient Sequence Number: 1
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