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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 10/31/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, it was reported that the vns patient was experiencing an ectopic heartbeat that began on (b)(6) 2012, and resolved that same day. The patient recovered without sequelae. The patient was noted to have premature ventricular contraction and this ectopic heartbeat was moderate in severity. It was reported to not be related to the vns implant but the relationship to stimulation was probable; at the time of stimulation, the ectopic heartbeat was appearing. It was intermittent. The pulse width was reduced to 130usec and the output current was increased to 0. 5ma but the patient had frequent coughing and therefore the patient was kept at an output of 0. 25ma and pulse width of 130usec. It was also reported that the patient was experiencing a burning sensation in their eyes that began on (b)(6) 2012, and resolved on (b)(6) 2012. It was reported that the burning sensation in the patient's eyes was not related to the vns implant but possibly related to vns stimulation. The event was continuous. No actions were taken for the event and the patient recovered without sequelae. The patient had mild severity of burning sensation in both eyes and itching at the time of sensation. There was no decrease in vision at the time of the event and there was no gritty sensation, redness, watering, or discharge either. The patient did not go for consultation for this event but the patient used cineraria maritin schuade eye drops for two times at the time of burning sensation from (b)(6) 2012. It was later reported that patient also experienced giddiness and weakness that began on (b)(6) 2012, and resolved on (b)(6) 2012. These events were not related to vns implantation but were possibly related to vns stimulation and both events were mild. These events were continuous. No action was taken for the events and the patient recovered without sequelae. The patient was not subject to any consultation with doctors regarding the giddiness. No action was taken regarding the events. It was reported that on (b)(6) 2012 the patient had his second titration visit where the patient was increased to 0. 5ma but experienced a cough and the current was decreased back to 0. 25ma; the cough then disappeared. The patient was kept at an output of 0. 25ma. From the next day, (b)(6), 2012, the patient started having burning sensation in the eyes, giddiness, and weakness. No consultation was taken with an ophthalmologist, neurologist, or physician for the adverse events. The patient has a past medical history of dilated cardiomyopathy, mild mr, severe lv dysfunction (lvef-30%), acute decompensated heart failure (nyha class ii). The patient has no history of shortness of breath even on exertion and no history of chest pain, syncope, or giddiness. The patient had a coronary angiography in (b)(6) 2006 which showed normal coronaries. A 2-d echo cardiography dated (b)(6) 2012 showed a dilated lv, global hypokinesia of lv, severe lv dysfunction (lvef-31%), moderate mr/mild tr, mild pah/no clots. A chest x-ray dated (b)(6) 2012 had noted cardiomegaly. Additional information has been requested but no further information has been received to date.

 
Event Description

Additional information was received on (b)(6) 2013 when the physician reported that diagnostics were within normal limits. The patient's settings were noted to be output=1ma/frequency=10hz/pulse width=250usec/on time=14sec/off time=1. 1min/magnet output=0ma/magnet on time=60sec/magnet pulse width=500usec. The patient was noted to have a history of dilated cardiomyopathy, severe lv dysfunction, no "ccf", and "nyha class ii".

 
Event Description

Additional information was received on (b)(6) 2013 when it was reported that the vpcs were too frequent so the ectopic heartbeat was moderate. The ectopic heartbeat was determined to be not related to vns stimulation.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
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 Key2870871
Report Number1644487-2012-03277
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2014
Device MODEL Number103
Device LOT Number202136
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/13/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/21/2012
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: 12/12/2012 Patient Sequence Number: 1
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