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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 01/01/2006
Event Type  Death  
Event Description

It was reported via scientific article "exacerbation of electrical storm subsequent to implantation of a right vagal stimulator" by shalaby aa, et al. That a pt with advanced ischemic cardiomyopathy underwent implantation of a vagal stimulator in an attempt to control recurrent drug refractory ventricular tachycardia. Four years prior, the pt had an implantable defibrillator (icd) inserted. Electrical storm was exacerbated after the implant of vns and continued after neurostimulation was discontinued. Stimulation was discontinued 24 hrs following implant of vns. Per article, "all vt events after vagal stimulator implant were noted to follow a peculiar diurnal distribution with a clear morning bias (3-11 am) not noted in previous events". The pt subsequently requested to have his icd turned off following events and he died 2 weeks later in hospice care. The report aims to provide a cautionary note to application of vagal stimulation for control of cardiac arrhythmia. However, per the article, "it is possible that the relapse of electric storm after vagal stimulator implant was unrelated to the implant but rather to progression of underlying disease, fluctuations in drug levels or possibly intracellular electrolyte levels". No conclusion could be drawn based on the article. Attempts for further info are in progress.

 
Manufacturer Narrative

Shalaby aa, el-saed a, nemec j, moosy jj, and balzer jr. "exacerbation of electrical storm subsequent to implantation of a right vagal stimulator". Clin auton res. (2007).

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceUNKNOWN
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1564916
Report Number1644487-2009-02839
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/20/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/20/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/18/2009 Patient Sequence Number: 1
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