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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 Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the patient had three breakthrough seizures, but the physician had also stopped the patient's vimpat. Diagnostics were performed, which confirmed that the device was functioning properly. No further relevant information has been received to date.

 
Event Description

It was reported that the patient's tie-down was protruding at the neck incision. It was stated that the patient has not had efficacy possibly from the lead being placed too low also causing side effects. It was alleged that the patient started feeling a burning sensation and vibrating in the throat with auto-stimulation. It was thought that the increase in seizures could have caused the patient to have more autostimulations than usual, which caused the burning/vibrating in the neck area. The device was then disabled in may due to the burning sensation and vibrating in throat. No additional relevant information has been received to date.

 
Event Description

Additional information was received that the device was likely disabled around (b)(6) as the patient was seen in the emu at this time. No additional or relevant information has been received to date.

 
Event Description

Information was received indicating that the patient is scheduled for a full replacement. Surgery is likely but has not been completed to date. No additional or relevant information has been received to date.

 
Event Description

The patient underwent a full explant. It was stated that x-rays were reviewed and revealed that the device was too low and the electrodes did not appear even on the nerve the explanted devices have not been received for analysis to date. No additional or relevant information has been received to date.

 
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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 Key6566145
Report Number1644487-2017-03798
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/20/2017
Device MODEL Number106
Device LOT Number203494
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/01/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/31/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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