MAUDE Adverse Event Report: CYBERONICS, INC.NCP PULSE GENERATROPULSE GENERATOR

Model Number 101

Event Date 05/02/2005

Event Type  Injury   Patient Outcome  Life Threatening

Manufacturer Narrative

Report is incomplete because no response has been received to mfr's requests for additional information from treating neurologist.

Event Description

Reporter indicated that after increasing programmed parameters, the pt experienced a choking sensation. During the episode, the pt's eyes became dilated and pt passed out. Treating neurologist was unable to get a pulse for a short period of time, but reported that the pt regained consciousness after prgrammed settings were reduced to original parameters. The pt was sent home in good condition after resting in the doctor's office. It was reported that programmed parameters were increased due to an increase in seizures activity; however, investigation to date has been unable to determine whether the increase was above pre-vns baseline frequency. At follow-up office visit two days later, device diagnostic testing with within normal limits, indicating proper device function. Normal mode output current was reduced from 1. 25ma to 1. 0ma.

• Brand Name: NCP PULSE GENERATRO
• Type of Device: PULSE GENERATOR
• Baseline Brand Name: NCP PULSE GENERATOR
• Baseline Generic Name: PULSE GENERATOR
• Baseline Catalogue Number: NA
• Baseline Model Number: 101
• Baseline Device Family: NA
• Baseline Device PMA Number: P970003
• Baseline Shelf Life Information: Yes
• Is Baseline 510(K) Number Provided?: No
• Baseline Preamendment?: No
• Transitional?: No
• 510(K) Exempt?: No
• Shelf Life(Months): 18
• Date First Marketed: 02/01/2000
• Manufacturer (Section F): CYBERONICS, INC.; houston TX *
• Manufacturer (Section D): CYBERONICS, INC.; houston TX *
• Manufacturer Contact: darlene garner, rac ; 100 cyberonics blvd.; houston , TX 77058; (281) 228 -7226
• Device Event Key: 603670
• MDR Report Key: 613869
• Event Key: 583513
• Report Number: 1644487-2005-00354
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2005

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/01/2005
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device EXPIRATION Date: 08/31/2003
• Device MODEL Number: 101
• Device LOT Number: 5316
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2005
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 02/01/2002
• 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