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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.PULSE GEN MODEL 101

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CYBERONICS, INC. PULSE GEN MODEL 101   Back to Search Results
Model Number 101
Event Date 12/04/2008
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Manufacturer Narrative

Article citation: iriarte, jorge, elena urrestarazu, manuel alegre, alfonso macias, asier gomez, paola amaro, julio artieda, and cesar viteri. "late-onset periodic asystolia during vagus nerve stimulation. " epilepsia 49 (2008): 1-5.

 
Event Description

It was reported in a scientific article that a vns patient, who had been receiving vns therapy for nine years without complaint, was admitted to the hospital for the control of an episode status epilepticus, an event not uncommon for the patient, for which medication was administered. The patient experienced an increase in seizures during the hospital stay and eeg monitoring revealed the occurrence of periodic cardiac changes with bradyarrhythmia and often severe asystolia due to atrium ventricular block, which coincided with stimulation. The patient was admitted to the cardiac intensive care unit and underwent holter monitorization, because the periodicity of the bradyarrhythmias was the same as that of the ncp stimulation (around 30 s every 5. 5 min), the ncp was stopped. Once the device was disabled, the reported arrhythmia event resolved. The reporter states that though there appears to be a clear relationship to vns therapy, other contributing factors were believed to be present. These factors include the addition of levetiracetam, which had a notable arrhythmic effect on the patient. The author also suggests that the patient's status episode may have predisposed the patient to the vns-related cardiac arrhythmia.

 
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section F)
CYBERONICS, INC.
houston TX
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
(281) 228 -7200
Device Event Key1337924
MDR Report Key1276878
Event Key1218449
Report Number1644487-2008-03112
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/31/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number101
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received12/12/2008
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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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