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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 06/18/2010
Event Type  Injury  
Event Description

Although vns explant surgery is likely, it has not occurred to date.

 
Event Description

A nurse practitioner at a neurologist's reported on (b)(6) 2012, that a patient was experiencing bradycardia with vns stimulation, and the patient will likely have his device removed as a result. The patient is also being monitored by a cardiologist who has noted that the patient has second- and third-degree heart block during stimulations. She also indicated that he was having a drop in blood pressure during these bradycardia events causing syncope. Due to the adverse events, she expects the device to be explanted, but they are waiting for the cardiologist evaluation to be completed. They first confirmed the bradycardia and syncope on (b)(6) 2012, but she suspects that this has been an on-going issue since the patient was turned on ((b)(6) 2010). The patient is noted as being a poor historian due to issues with alcohol abuse and appointment compliance, and she feels that he cannot tell the difference between a seizure and a syncopal event, which is why she feels that this has been an issue since after implant. She does not feel that the device is malfunctioning, but the placement of the electrodes is the likely cause. She mentioned that they were able to induce an event with the magnet activation, which is how they confirmed the events occurring with stimulation. When asked if the events are occurring with normal mode stimulation, she said that she believed so, which is why there is question about the previous seizures possibly being syncopal events. The events were not occurring with every normal mode activation. The patient's device is now disabled and is wearing a holter monitor to further determine if this event is occurring without stimulation. An ecg/cardiology monitor report was received indicating the patient's average heart rate is 64 bpm. The minimum heart rate was measured as 27 bpm, and the maximum heart rate was 101 bpm. The study concluded that the patient has complete heart block on (b)(6) 2012, at one point. A cardiology consult was placed for the electrophysiologist. The arrhythmia questionnaire was received from the neurologist's office reporting that the patient does not have a prior history of cardiac events nor does his family. The patient does have pre-existing medical conditions of tuberous sclerosis, sleep apnea, and major depression which are unrelated to vns. The patient has experienced 2nd degree type 1 and type 2, in addition to 3rd degree heart block. The patient's normal heart rate is about 64 bpm, but during the bradycardia it dropped to 27 bpm. This did not occur intraoperatively. No traumatic events, medication changes, or vns settings changes were experienced prior to the arrhythmia. The bradycardia occurs with the on time of vns stimulation but not during diagnostics. The neurologist's office believes the arrhythmia is related to vns stimulation. The patient has not been hospitalized for this event. Since the device was disabled, the patient reports that the bradycardia has not occurred again, but they are awaiting the holter monitor results.

 
Event Description

On (b)(4) 2013 information was received from the reporter that a case study was being published on this patient and event and that an abstract for the article had been received for the article. The article is ¿late-onset advanced heart block due to vagal nerve stimulation¿ by a. Schevchuck and m. B. West, published in the american journal of therapy on june 21, 2013. Figures #1 and #2, which display ekgs of the patient¿s normal sinus rhythm and sinus rhythm during vns stimulation showing advanced atrioventricular block, respectively, are figures not received in the past.

 
Manufacturer Narrative

 
Manufacturer Narrative

Describe event or problem, corrected data: the initial report inadvertently did not include this information.

 
Manufacturer Narrative

Article citation: american journal of therapy; 2013 jun 21. [epub ahead of print]; late-onset advanced heart block due to vagal nerve stimulation. Schevchuck a, west mb. Department of internal medicine, division of cardiology. (b)(6).

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2728697
Report Number1644487-2012-02233
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/16/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2011
Device MODEL Number102
Device LOT Number2538
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/27/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/08/2010
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: 09/06/2012 Patient Sequence Number: 1
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