MAUDE Adverse Event Report: CYBERONICS, INC.PULSE GEN MODEL 102

Model Number 102

Event Date 01/01/2009

Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization

Event Description

It was reported that a pt developed drop attacks in 2009 (approximately 7. 5 years after being implanted which lead to the pt being hospitalized. The pt also had periodic bradycardia. The device was programmed off and the bradycardia and drop attacks resolved. Additional information received from the pt's physician revealed that the pt does not have a history or a family history of cardiac events. The pt presented with syncope which suggested some sort of arrhythmia. The pt's heart rate prior to the event was 70 and decreased to 10 during the event. The blood pressure was 120/80 prior to the event; however, no blood pressure readings were provided after the event. There were no traumatic events, medication changes, or triggers such as smoking, caffeine intake, etc. That preceded the onset of the bradycardia. The pt is currently taking zonegran, lamictal, and topamax. The bradycardia did not occur during device diagnostics nor did it occur following a setting change. An ecg and polysomnography were performed to diagnosed the arrhythmia. The arrhythmia (bradycardia) is believed to be related to device stimulation and is exaggerated by the device. The pt was hospitalized for the length of testing needed to diagnose the arrhythmia. The arrhythmia has not recurred since the device has been programmed off. Good faith attempts to obtain additional information are currently being made.

• Brand Name: PULSE GEN MODEL 102
• Manufacturer (Section F): CYBERONICS, INC.; houston TX 77058
• Manufacturer (Section D): CYBERONICS, INC.; houston TX 77058
• Manufacturer Contact: nydia grimes ; 100 cyberonics blvd.; ste. 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 1602820
• MDR Report Key: 1558273
• Event Key: 1483620
• Report Number: 1644487-2009-02753
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2009

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/10/2009
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device EXPIRATION Date: 04/30/2010
• Device MODEL Number: 102
• Device LOT Number: 2064
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 11/16/2009
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/01/2008
• 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