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

Model Number 101

Event Date 03/03/2008

Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization

Event Description

Initial reporter called to ask if manufacturer had any info on vns pt's experiencing asystole caused by swiping their magnet or stimulation. It was additionally reported "a pt had a seizure and the nurse swiped with a magnet. Afterwards the pt went into asystole, which lasted several seconds. The pt was in the hospital due to seizures and connected to a monitor so they were able to see it. " the pt's seizure rate was above their pre vns seizure rate and was a change for the pt. No further info has been attained from the site after good faith attempts have been made.

• Brand Name: PULSE GEN MODEL 101
• Manufacturer (Section F): CYBERONICS, INC.; houston TX 77058
• Manufacturer (Section D): CYBERONICS, INC.; houston TX 77058
• Manufacturer Contact: michael carroll ; 100 cyberonics blvd.; ste 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 989849
• MDR Report Key: 1022608
• Event Key: 981279
• Report Number: 1644487-2008-00827
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2008

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/01/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device EXPIRATION Date: 12/31/2001
• Device MODEL Number: 101
• Device LOT Number: 40548C
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 03/05/2008
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 07/14/2000
• 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