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

Model Number 101

Event Date 01/11/2002

Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization

Event Description

Rptr indicated that pt had explanted self. It was reported that the pt went into the restroom and when the pt came out, the generator was out of the pt's chest. The pt opened the healed incision. The pt had apparently pried the generator out with the pt's hands. The pt picked at it until the pt got it out. The pt's lead was explanted by surgeon and the pt was prescribed a prophylactic ten-day dose of amoxicillin. There are no plans for re-implant. Further f/u revealed that the pt was seen in 2002 at which time the pt's staples were removed and the pt was reported to be healing fine from the explant procedure. No further appointments are scheduled.

• Brand Name: NCP PULSE GENERATOR
• 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.; 16511 space center blvd., #600; houston TX 77058
• Manufacturer (Section D): CYBERONICS, INC.; 16511 space center blvd., #600; houston TX 77058
• Manufacturer Contact: darlene garner, rac ; 16511 space center blvd.; ste. 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 366684
• MDR Report Key: 377618
• Event Key: 356372
• Report Number: 1644487-2002-00055
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2002

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/18/2002
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device EXPIRATION Date: 11/30/2002
• Device MODEL Number: 101
• Device LOT Number: 3071
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 02/01/2002
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2002
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 05/01/2001
• Is The Device Single Use?: Yes
• Is the Device an Implant?: Yes

Is this an Explanted Device?

• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 02/18/2002 Patient Sequence Number: 1

#	Treatment	Treatment Date
MODEL 300-30 NCP BIPOLAR LEAD,
EXPIRE DATE 1/31/2002, DATE OF MFG 12/22/1999,
STERILIZATION LOT NO. 32937C.