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 Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Neck Pain (2433); No Code Available (3191)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient was having issues with his new device.He reported pain and swelling on the left side of his neck, shoulder, jaw, and was having muscle spasms on the left side of his neck, he felt a lead pulling sensation across his neck and chest, and he had coughing associated with stimulation.The patient also said that it looks like he has an infection.The physician later reported that diagnostics were run and were within normal limits.She stated she had decreased the output current to attempt to alleviate the issues.The patient was scheduled for a follow-up appointment but did not show up.The physician noted she had referred the patient to a surgeon who is more experienced with vns.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Information was received that after the patient's consult with the surgeon, he was referred for a lead revision.The surgery was scheduled but the patient was initially a no-show.The surgery has been rescheduled but has not been completed to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Lead revision surgery occurred.The explanted device was discarded by the explant facility.

• 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: 6316710
• MDR Text Key: 67090135
• Report Number: 1644487-2017-03178
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/27/2018
• Device Model Number: 106
• Device Lot Number: 203837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2016
• 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: 57 YR