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

Model Number 101

Event Date 01/01/2004

Event Type  Injury  

Event Description

Pt's predominant seizures were noted as having an increase in the ictal severity of seizures at the 2-year follow-up. The pt was also noted as having tonic-clonic seizures at the most recent visit (3-years post implant) not previously noted for the pt, which appears to be an increase from baseline. A search performed in the mfr's programming history database did not reveal any details on the diagnostics for the device. Good faith attempts to obtain add'l info 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: 2230508
• Report Number: 1644487-2011-01858
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/14/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/12/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 05/31/2003
• Device MODEL Number: 101
• Device LOT Number: 4813
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 07/14/2011
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 12/01/2001
• 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: 08/12/2011 Patient Sequence Number: 1