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

Model Number 102R

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

Patient Problems Chest Pain (1776); Pain (1994)

Event Date 01/23/2018

Event Type  Injury  

Event Description

Clinical notes were received indicating the patient was feeling pain in her chest around the vns implant and painful stimulation in her left chest.The neurologist's notes stated the generator battery is likely at its end of life but no battery indicator was noted.The notes also stated the device's impedance value was normal when accessing the vns system, but no impedance value was provided.The patient was referred for generator replacement due to these events.No known surgical intervention has occurred to date.No additional or relevant information has been received to date.

Event Description

A fax was received from the patient's neurologist that indicated the replacement was related to the painful stimulation and provided recent system diagnostics.Both the generator and lead were subsequently replaced.Both devices have been received.Analysis is underway but has not been completed to date.No additional or relevant information has been received to date.

Event Description

Product analysis for the returned generator and lead has been completed and approved.The generator's output signal was monitored for more than 24-hrs with the generator placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and that the device provided the expected level of output current for the entire monitoring period.There was no indication that an end of service condition existed.The pulse generator diagnostics were as expected for the programmed parameters.The device performed according to functional specifications analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.The lead was returned in two portions.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 portions.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102R
• 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: 7304009
• MDR Text Key: 101198542
• Report Number: 1644487-2018-00299
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2009
• Device Model Number: 102R
• Device Lot Number: 1972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Other
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2007
• 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
• Patient Age: 45 YR