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

Event Date 10/01/2009

Event Type  Injury  

Event Description

It was reported by a neurologist that a vns pt was experiencing palpitations. The pt has been seizure free and had placed a magnet over her vns device for the past 1. 5 years. According to treating neurologist, the pt has long q-t interval but hasn't seen a cardiologist. The physician did not know if pt's cardiac symptoms have subsided since he just inherited the pt from another physician. Good faith attempts to obtain more info regarding pt's adverse event have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL UNK
• Manufacturer (Section D): CYBERONICS, INC.; houston TX
• Manufacturer Contact: nydia grimes ; 100 cyberonics blvd.; ste. 600; houston , TX 77058 ; 2812287200
• MDR Report Key: 2039448
• Report Number: 1644487-2011-00685
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/01/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/31/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 03/01/2011
• 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
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 03/31/2011 Patient Sequence Number: 1