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

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seizures (2063); Neck Pain (2433)

Event Type  Injury  

Event Description

It was reported that a patient's vns generator was explanted.The patient felt vns was making her seizures worse and was causing her pain in the neck.It is unknown if this pain was associated with stimulation.The patient also felt that vns did not help her seizures.Attempts for additional relevant information have been unsuccessful to date.The explanted generator has not been returned to the manufacturer for analysis to date.

Event Description

Further follow-up revealed that the physician indicated the increase in seizures was not related to vns.The seizures were not an increase above the patient's pre-vns baseline frequency.Clinic notes on (b)(6) 2015 note that the patient would like her vns removed because it is more trouble than it's worth.The explanted generator and lead were received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the generator was completed on 10/29/2015.The device performed according to functional specifications.Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition.Analysis of the lead was completed on 11/06/2015.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

• 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: 5115756
• MDR Text Key: 27202083
• Report Number: 1644487-2015-05927
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2012
• Device Model Number: 102
• Device Lot Number: 2740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention