MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

Model Number 102

Event Date 11/20/2014

Event Type  Malfunction  

Event Description

It was reported that the patient's generator was unable to be interrogated. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description

On (b)(6) 2016, it was confirmed that the patient's device was able to be interrogated. Patient was seen at the neurologist's office due to recent increase in seizures to evaluate her for continuation of her vns therapy or replacement since her device disablement on (b)(6) 2008 due to seizure freedom. A diagnostic test was performed and patient was able to feel vns stimulation. During the stimulation period of the diagnostic test, patient experienced pain with stimulation in neck area pulled away before the test was completed. Additional information was received that the patient's diagnostic test results were not available as they could not be completed.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston , TX 77058 ; 2812287200
• MDR Report Key: 4330779
• Report Number: 1644487-2014-03326
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,COMPANY REPRESENTATIVE
• Reporter Occupation: HEALTH PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 11/20/2014

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/15/2014
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 07/31/2005
• Device MODEL Number: 102
• Device LOT Number: 008950
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Other
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/12/2003
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial