MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Chest Pain (1776); Neck Pain (2433)

Event Date 10/26/2017

Event Type  Injury  

Event Description

The surgeon reported that the patient was having pain at the implant site.The surgeon stated that everything looked good and that the generator was sitting well in the pocket, and that the wires seem to be intact and correctly located.The patient felt the pain at the electrode site during stimulation and described it as a shocking sensation during magnet stimulation.The doctor believed the patient was doing well and there were no issues with the generator or lead.Diagnostics were within normal limits and the settings were felt not to be contributory to the patient's pain, but the patient was complaining of pain at the generator site.The patient has been referred for surgery.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Surgery has been completed for this patient's generator replacement.The product has not been received by the manufacturer to date.No other relevant information has been received to date.

Event Description

Additional information was received that the explanted product is held for 2 years and 3 months by risk management at the explant facility before the product will be returned to the manufacturer.The product has not been received by the manufacturer to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 7154501
• MDR Text Key: 96042286
• Report Number: 1644487-2017-05088
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2019
• Device Model Number: 106
• Device Lot Number: 204008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• 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: 47 YR