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

Model Number 101

Event Date 06/23/2011

Event Type  Injury  

Event Description

It was reported by the patient's mother that the patient had an increase in seizures. The patient had not been seen by a physician since 2008, and the mother felt the device was no longer working. The patient was in attempts to obtain a replacement surgery. A review of the manufacturer's programming history showed the patient's last known settings and diagnostics were on (b)(6) 2007. The device was properly functioning at this time. A revision surgery in the future is likely. Attempts for further information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 101
• Manufacturer (Section D): CYBERONICS, INC.; houston TX 77058
• Manufacturer Contact: nydia grimes ; 100 cyberonics blvd.; ste 600; houston , TX 77058 ; 2812287200
• MDR Report Key: 2196483
• Report Number: 1644487-2011-01741
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: NOT APPLICABLE
• Type of Report: Initial
• Report Date: 07/06/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/03/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device EXPIRATION Date: 10/31/2003
• Device MODEL Number: 101
• Device LOT Number: 7151
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Date Manufacturer Received: 07/06/2011
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 10/01/2002
• 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: 08/03/2011 Patient Sequence Number: 1