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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/01/2011
Event Type  Injury  
Event Description

The patient reported that she was diagnosed with left vocal cord paralysis by an ent in 2012. It was reported that the patient's neurologist has not programmed the device off to assess whether or not the paralysis is related to vns therapy. The patient reported that her neurologist "performed something that shocked her" in 2011 and since then she has had voice changes. The neurologist's office indicated that the patient¿s vocal cord paralysis could be related to vns therapy, but that the device has been very effective in helping to control the patient¿s seizures so they are not changed any device settings at this time. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

Follow up with the physician's office confirmed that the patient's left vocal cord paralysis was diagnosed by an ent. The patient's last appointment was in (b)(6) 2012. The patient has a history of myasthenia gravis (neuromuscular disease leading to fluctuating muscle weakness) that is not related to vns. Per clinic notes, the nurse noted that it looks like the patient "is developing increasing hoarseness. She had an ent evaluation which did show left vocal cord paralysis. " she also has eye droop which is from myasthenia, not vns. The nurse noted that they cannot ruled out the myasthenia as the potential cause for the difficulty swallowing and left vocal cord paralysis. The physician notes that they could remove the vns, but he indicates that he has discussed this in length with the patient and he cannot state that the laryngeal nerve would return to function even after vns removal. Per notes, "although it is possible that the vns electrodes have caused corrosion on the left laryngeal nerve, i have never experienced this in my cases" and the physician does not suspect this is the case. The patient understands and does not want surgery. She would rather keep vns because it seems to be controlling her seizures. Between (b)(6) 2013, the patient did not have any seizures. The patient is reportedly at "appropriate" settings (not specifically provided) which are helping her with her seizures so they do not want to change the settings. The physician confirmed that since the patient's seizures are well controlled, they do not want to try and change the patient's settings to see if it affects the vocal cord paralysis. At this time, the patient's voice is not worse but still scratchy. They performed an x-ray which showed the vns system was not broken. Copy of x-rays will not be provided to the manufacturer for review. It was indicated that the patient's medications were adjusted to a dose that would help her with myasthenia, but the patient is kind of self-adjusting on her medications. Diagnostics are within normal limits, and the nurse again indicated that they interrogated the device and "settings are where they need to be. The nurse was unsure of what the patient was referring to when she said she was "shocked" at her last visit, but stated that the vns cannot be ruled out it was in relation to the nerve. No additional information was provided.

 
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Brand NamePULSE GEN MODEL 102
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 Key3272783
Report Number1644487-2013-02353
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 07/15/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2009
Device MODEL Number102
Device LOT Number200622
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/13/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/27/2007
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: 08/08/2013 Patient Sequence Number: 1
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