MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Hypoesthesia (2352); Neck Pain (2433)

Event Date 10/17/2017

Event Type  malfunction  

Event Description

It was reported that the patient was complaining of sternal pain with stimulation.However, the vns settings were lowered in steps and eventually disabled with no relief.The vns was programmed back on.The patient was referred for prophylactic vns generator replacement.Clinic notes were later received that indicated that the patient's pain was just below the site of his vns generator and was sharp with some mild radiation down the chest.Over the counter pain medication had limited effect and the patient was prescribed a topical lidocaine.Imaging was reviewed by the physician's office, but not the manufacturer, and no gross issues were noted.The patient was then referred for full vns replacement surgery per the clinic notes.The patient underwent only vns generator replacement surgery.The explanted generator was received by the manufacturer and is pending product analysis.It was later reported that the patient was still experiencing pain after the vns generator replacement surgery.The patient reported that for two days postoperatively, there was no pain, but shortly after, the patient began to experience the pain again.The pain was not associated with vns stimulation, but the patient reported that it was a tingling sensation that radiated into his neck.It was noted that the incision from the generator replacement surgery was well healed.There was no indication of damage on the lead during the vns generator replacement surgery.However, the patient is being referred for vns lead replacement surgery to attempt to alleviate the pain.No additional relevant information has been received to date.

Event Description

Product analysis was completed on the explanted vns generator.Proper functionality of the vns generator was confirmed in the product analysis, or pa, lab.The generator was placed in a simulated body temperature environment and the output signal was monitored for more than 24 hours.No variations in the output signal were observed and the generator provided the expected level of output current.The generator performed according to functional specifications.The generator communicated normally and no eri flag was set "as received." there were no abnormal performance or other adverse conditions found with the generator.

Event Description

The explanted lead was received by the manufacturer, indicating that the patient underwent lead replacement surgery, and is pending product analysis.

Manufacturer Narrative

Describe event or problem, corrected data: follow-up #3 inadvertently left out 'the lead tie-down is not expected to be on the nerve.' (b)(4).

Event Description

The lead tie-down is not expected to be on the nerve.

Event Description

Lead product analysis was completed.The allegations could not be evaluated in the product analysis, or pa, lab.A portion of the lead containing the electrodes was not returned and, therefore, a complete evaluation could not be performed.Continuity tests passed.There was no evidence of an anomaly on the returned portions of the lead.The condition of the returned lead was consistent with those found following explant.No obvious anomalies were identified.Follow up with the medical professional's office revealed that the there were notes from an ent prior to the generator replacement surgery that indicated that the pain may due to a "corrosion" of the lead or that the lead could be okay and could have just been backed out of the generator.The operative notes indicated that the lead appeared to be intact, but with a slightly loose connection.The lead was not replaced at the time, but recoiled.However, several weeks later, a lead replacement surgery was documented.It was stated that the patient was still experiencing pain that radiated to the neck.During surgery, the surgeon followed the lead to the neck and found that the "tie down lead" did not appear to be on the nerve.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7030468
• MDR Text Key: 92016857
• Report Number: 1644487-2017-04776
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2014
• Device Model Number: 302-20
• Device Lot Number: 2643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2010
• 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
• Patient Age: 31 YR