MAUDE Adverse Event Report: CYBERONICS, INC.VNS THERAPY PULSEPULSE GENERATOR

Model Number 102

Event Date 01/01/2004

Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening,Required Intervention

Event Description

Further follow-up (discharge summay dated 2004) revealed that the pt originally received the vns system so that he coul reduce the medications he was taking. The vns did not appear to help, and the pt reportedly began to have recurring and more-frequent events. The pt reported that 80% of the seizures are without warming and 20% are preceded by the sensation of jejavu. The pt feels "generally not right" and has difficulty breathing. He will suddenly stop what he is doing and become pale. His lips will turn blue and he will fall from standing. He denies any convusions. The episodes last 20-30 seconds, sometimes accompanied by brief myoclonus and followed by postictal confusion of 1-20 minutes. There is frequent urinay incontinence but rarely bowel incontinence. The pt was admitted to the impatient monitoring svc to better identify and classify his events for the initial evaluatio of possible surgical intervention. The pt was placed on continuous video-eeg monitoring. He had normal waking background alpha frequency of 11 hz with normal drowsiness and sleep stages identified. The pt had normal, if any, identifable interictal epileptiform discharges. He had several clinical events recorded. The pt had an event where he went from his prior sinus heart rate to a progressive bradycardia,culminating in a 15-second pause that was followed by generalized flattering of the eeg background, followed by some generalized delta events. After this event a cardiology consult was obtained. This was the event that prompted the initial medwatch report. There was concern that the vns system may have contributed to the event, therefore, the vns device was deactivated. Because the pt had the vns device for quite sometime before the asystole event, it was felt by the epilepsy svc to be exceedingly unlikely that the vns device contributed to the episode of asystole. Following the initial event, the pt had several more events, though none were accompanied by significant asystole. It was reported that the episode of asystole may have been triggered by a subtle seizure activity involving the frontal lobe, and there was no way to guarantee that this would not recur. The vns device was not turned back on at this point and it is unk if the vns device is presently activated.

Manufacturer Narrative

Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist. H. 6. Vns therapy system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation.

Event Description

Reporter indicated that vns patient was experiencing episodes of asystole. The cause of the episodes is unknown. The patient was subsequently implanted with a pacemaker. The patient's vns therapy system was programmed to off prior to the pacemaker implant surgery and was programmed to on at certain points during the pacemaker implant surgery to assess whether the vns therapy affected the pacemaker sensing capabilities. When the pacemaker leads were implanted and connected to monitoring equipment, the vns therapy system was programmed to on at 1. 0ma output current. There were no changes to the monitoring equipment while the device was programmed to on at 1. 0ma output current. Normal mode output current was then increased from 1. 0ma to 2. 0ma with no changes to the monitoring equipment. Due to patient discomfort, the vns therapy system was programmed back to 0ma after approximately 10 seconds. The pacemaker battery was then implanted and connected to the pacemaker leads. The vns therapy system was then programmed to on at 3. 5ma normal mode output current in order to test the vns generator with the pacemaker and the pacemaker's monitoring equipment. After approximately 10 seconds, the vns therapy system was programmed back to off. Upon completion of the pacemaker implant surgery, the vns therapy system was interrogated to confirm that the device was programmed to off (0ma output current). Investigation to date has been unable to determine whether a relationship exists between the episodes of asystole and the vns therapy system. The patient's neurologist indicated that he was not aware of the patient having cardiac problems prior to the vns implant.

• Brand Name: VNS THERAPY PULSE
• Type of Device: PULSE GENERATOR
• Baseline Brand Name: VNS THERAPY PULSE
• Baseline Generic Name: PULSE GENERATOR
• Baseline Catalogue Number: NA
• Baseline Model Number: 102
• Baseline Device Family: NA
• Baseline Device PMA Number: P970003
• Baseline Shelf Life Information: Yes
• Is Baseline 510(K) Number Provided?: No
• Baseline Preamendment?: No
• Transitional?: No
• 510(K) Exempt?: No
• Shelf Life(Months): 24
• Date First Marketed: 06/20/2002
• Manufacturer (Section F): CYBERONICS, INC.; houston TX *
• Manufacturer (Section D): CYBERONICS, INC.; houston TX *
• Manufacturer Contact: darlene garner ; 100 cyberonics blvd.; ste. 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 556441
• MDR Report Key: 566648
• Event Key: 538383
• Report Number: 1644487-2005-00070
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2004

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/20/2005
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device EXPIRATION Date: 01/31/2006
• Device MODEL Number: 102
• Device LOT Number: 10275
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2004
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 02/01/2004
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: Yes

Is this an Explanted Device?

• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 01/20/2005 Patient Sequence Number: 1

#	Treatment	Treatment Date
MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE
02/28/2006, DATE OF MFG 02/26/2004, STERILIZATION
LOT NO. 10275.