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

Model Number 102

Event Date 09/07/2007

Event Type  Malfunction   Patient Outcome  Hospitalization,Other,Life Threatening,Required Intervention

Event Description

The reporter indicated the pt was admitted to cardiac care unit for monitoring. The pt experienced an asystole and bradycardia, approx five or six mos ago. The pt was seen for video monitoring for his seizures. During the monitoring, the reporter noted that "the pt would go into "true persistent asystole with no pulse. " in addition, the pt had an asystole only during a magnet swipe which was set for 60 seconds on. The reporter stated the pt's magnet output current was set to 3. 5 ma. The reporter indicated the normal stimulation was set to 1. 5 ma. The reporter stated "the pt was having a seizure and they swiped the device initiating a magnet mode stimulation. " the reporter noted the asystole was longer, than when they swiped the pt without a seizure. The reporter stated "the asystole and bradycardia are directly related to vns stimulation. " during the pt's admission in the ccu, the reporter lowered the magnet output current to see how the pt would respond to the new settings. The reporter stated the pt was set to 2. 25ma. Thus, the pt no longer had asystole, but bradycardia. The reporter states "this setting does not help the pt's seizures to abort, but the cardiologist was fine with the bradycardia. " the reporter stated "the pt is fine now, just not getting as good of seizure control with the new setting. " good faith attempts to obtain additional info are in progress and awaiting results.

• Brand Name: PULSE GEN MODEL 102
• Manufacturer (Section F): CYBERONICS, INC.; houston TX
• Manufacturer (Section D): CYBERONICS, INC.; houston TX
• Manufacturer Contact: michael carroll ; 100 cyberonics blvd.; ste 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 1008290
• MDR Report Key: 1009251
• Event Key: 887768
• Report Number: 1644487-2008-00640
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Company Representative,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2008

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/07/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device EXPIRATION Date: 08/31/2005
• Device MODEL Number: 102
• Device LOT Number: 009405
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 02/08/2008
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 10/01/2003
• 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