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

Model Number 101

Event Date 12/04/2008

Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening

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.

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.

• Brand Name: PULSE 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 Key: 1337924
• MDR Report Key: 1276878
• Event Key: 1218449
• Report Number: 1644487-2008-03112
• Device Sequence Number: 1
• Product Code: LYJ
• 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 Received: 12/31/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device MODEL Number: 101
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 12/12/2008
• 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