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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 01/01/2010
Event Type  Injury  
Event Description

Upon further follow up with the nurse, it was revealed that the patient is experiencing pain and a "shocking sensation in chest due to wires being bunched up". The lead appears to be protruding from mid-neck to the collarbone with a "knot" felt at the lead body. The only intervention taken to date is assessment by the surgeon. Both the surgeon and the treating vns physician tested the device, and it was reported to be working okay. The patient's severe body spasms are believed to be the likely cause of the lead protrusion and caused the extreme pain and feeling of being shocked. No other physiological changes are believed to have contributed to the lead protrusion. Since the surgeon is afraid the lead wires may break if not replaced and due to the length of implant, the patient is referred for full revision surgery. Although surgery is likely, it has not occurred to date.

 
Event Description

It was reported on (b)(6) 2013, that the patient is experiencing lead wires "bulging" accompanied with tension/pain in the neck that occurred right after she had a severe episode of body spasms about 10 days prior. The patient has a variety of physical illnesses, one of which includes these body spasms. The treating rn believed the body spasms may have been experienced as an extreme case due to stress as the patient was on her way to her brother's funeral. She also thought that the protrusion was due to the spasms that the patient experienced. The rn also mentioned that the patient's depression had been worsening recently, but that she believes that the patient's stress (brother passing away, dog being ill) have contributed to this recent increase in depression. The patient was evaluated again by the treating vns psychiatrist on (b)(6) 2013. Diagnostics on the patient's vns are within normal limits. The psychiatrist reports that the lead "bulging out a little bit like a vein" but was unsure if this bulge has always been there all along. Later, it was reported that the patient has also been experiencing pain and swelling in the tongue due to little cuts on her tongue which occurs with stimulation, and the surgeon believes this is related to vns. The patient has been experiencing this for a while; however, it has worsened lately with the other events. The treating rn did not have further details at that time. Clinic notes from the surgeon dated (b)(6) 2013, indicate that the patient complains of tension/pain in the left neck/leads and had been worsening over the past few years. The surgeon indicated in the notes that he can offer operation for lead revision for severe excess lead tension and generator change for end of life which the patient agreed. The patient was scheduled for surgery for possible generator and lead revision due to pain and swelling with stimulation. The surgeon reportedly believes the patient does not need an x-ray because he can see the wires bunched "where it goes into the vns. " as of (b)(6) 2013, the rn reported the patient indicates that she has a "white line in her skin going along the vagal nerve" and a knot at the electrode site which the patient and physician can feel. The rn also indicated that the patient has a lot of accompanying medical, physical and psychological problems. Although surgery is likely, it has not occurred to date. Attempts for additional information from the treating psychiatrist's office ( rn) have been unsuccessful to date. Follow up with the surgeon's office revealed that per the psychiatrist's notes, the patient "denies any pain or discomfort from vns. She has been diagnosed with major depression disorder and major psychotic disorder which may be a psychotic manifestation of her symptoms. Would like to rule out psychotic or psychological disorder. " the nurse indicated that the surgeon appears to be due to not to preclude a serious injury as the notes indicate that she denies pain or discomfort and the symptoms appear to be thought to be related to her other mental/physician illnesses. However, it remains unclear at this time.

 
Manufacturer Narrative

 
Manufacturer Narrative

The initial report inadvertently reported the age incorrectly as the date of event was listed incorrectly. The initial report inadvertently reported the event date incorrectly as it was reported that the tension and pain in the neck was worsening over the past couple of years.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key3027374
Report Number1644487-2013-00865
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/04/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/29/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/08/2009
Device MODEL Number302-20
Device LOT Number202254
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/23/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/14/2006
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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